FDA event 86777 · Recall Observatory

device · product 1 of 37

IceFORCE" 2.1 CX 90¿ Cryoablation Needle

Z-0657-2021

Recall number: Z-0657-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 22,289 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3602 UDIs: 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003, 7290104831003 Batch Numbers: U1397, U1395, U1359, U1357, U1396, U1394, U1355, U1353, U1351, U1349, U1347, U1338, U1340, U1342, U1344, U1346, U1348, U1354, U1352, U1358, U1356, U1350, U1345, U1341, U1343, U1339, U1298, U1296, U1294, U1292, U1290, U1288, U1286, U1284, U1282, U1280, U1278, U1276, U1274, U1273, U1279, U1283, U1285, U1287, U1291, U1293, U1277, U1297, U1281, U1275, U1289, U1295, U1260, U1258, U1256, U1254, U1252, U1204, U1246, U1247, U1249, U1251, U1253, U1255, U1257, U1259, U1243, U1241, U1245, U1250, U1248, U1244, U1242, U1202, U1200, U1198, U1185, U1189, U1191, U1192, U1193, U1197, U1199, U1203, U1187, U1195, U1201, U1196, U1194, U1190, U1188, U1186, U1163, U1164, U1159, U1157, U1155, U1151, U1149, U1147, U1143, U1141, U1132, U1134, U1136, U1140, U1142, U1145, U1148, U1152, U1153, U1154, U1156, U1146, U1144, U1150, U1138, U1158, U1139, U1137, U1135, U1133, U1116, U1107, U1105, U1102, U1101, U1108, U1099, U1106, U1097, U1098, U1100, U1103, U1096, U1104, U1095, U1092, U1073, U1072, U1063, U1062, U1065, U1060, U1064, U1061, U1059, U1056, U1058, U1055, U1008, U1003, U1004, U1002, U1000, U0998, U0996, U0992, U0995, U1001, U1005, U1006, U1007, U0993, U0999, U0997, U0991, U0994, U0942, U0937, U0936, U0934, U0932, U0929, U0928, U0926, U0927, U0930, U0931, U0933, U0935, U0938, U0940, U0939, U0900, U0896, U0894, U0892, U0891, U0893, U0895, U0897, U0899, U0890, U0898, U0901, U0855, U0853, U0851, U0849, U0847, U0845, U0843, U0844, U0850, U0852, U0854, U0842, U0848, U0846, U0838, U0839, U0840, U0841, U0807, U0810, U0797, U0794, U0791, U0793, U0795, U0796, U0798, U0801, U0804, U0805, U0808, U0809, U0799, U0802, U0800, U0803, U0806, U0787, U0788, U0789, U0792, U0790, U0762, U0760, U0758, U0754, U0751, U0747, U0749, U0750, U0752, U0753, U0755, U0756, U0761, U0759, U0757, U0748, U0769, U0723, U0719, U0709, U0715, U0716, U0718, U0720, U0721, U0724, U0726, U0707, U0713, U0710, U0711, U0722, U0725, U0717, U0714, U0712, U0708, U0688, U0682, U0680, U0678, U0674, U0670, U0672, U0668, U0665, U0666, U0662, U0663, U0667, U0669, U0675, U0681, U0683, U0684, U0685, U0673, U0676, U0679, U0677, U0671, U0664, U0639, U0637, U0635, U0633, U0630, U0608, U0628, U0631, U0632, U0636, U0638, U0607, U0626, U0634, U0629, U0627, U0606, U0604, U0602, U0600, U0579, U0575, U0578, U0580, U0597, U0599, U0605, U0603, U0598, U0601, U0577, U0576, U0573, U0574, U0572, U0570, U0567, U0569, U0571, U0565, U0568, U0566, U0556, U0557, U0551, U0550, U0549, U0548, U0546, U0547, U0543, U0544, U0490, U0509, U0488, U0489, U0486, U0480, U0481, U0483, U0485, U0487, U0482, U0484, U0458, U0457, U0456, U0454, U0452, U0453, U0423, U0424, U0361, U0362, U0360, U0358, U0317, U0316, U0359, U0357, U0312, U0314, U0313, U0311, U0309, U0306, U0308, U0315, U0310, U0307, U0277, U0276, U0274, U0272, U0270, U0267, U0268, U0263, U0264, U0265, U0269, U0271, U0275, U0278, U0273, U0266, U0225, U0224, U0222, U0223, U0190, U0191, U0187, U0170, U0171, U0163, U0162, U0145, U0142, U0141, U0138, U0139, U0140, U0143, U0144, U0110, U0111, U0106, U0107, U0104, U0105, U0101, U0100, U0097, U0096, U0090, U0080, U0079, U0076, U0078, U0081, U0077, U0056, U0055, U0049, U0048, U0026, U0024, U0023, U0022, U0025, T0811, T0812, T0810, T0808, T0809, T0744, T0743, T0742, T0739, T0781, T0782, T0734, T0716, T0733, T0740, T0737, T0738, T0741, T0714, T0729, T0730, T0727, T0728, T0715, T0717, T0709, T0708, T0685, T0684, T0661, T0662, T0641, T0643, T0644, T0646, T0645, T0642, T0637, T0638, T0639, T0640, T0628, T0629, T0630, T0631, T0624, T0627, T0625, T0622, T0626, T0623, T0612, T0613, T0586, T0585, T0582, T0581, T0579, T0580, T0575, T0576, T0574, T0573, T0569, T0568, T0564, T0563, T0553, T0554, T0548, T0549, T0545, T0543, T0534, T0535, T0526, T0525, T0518, T0519, T0517, T0516, T0514, T0513, T0508, T0509, T0510, T0506, T0505, T0500, T0501, T0497, T0496, T0494, T0495, T0481, T0482, T0479, T0480, T0478, T0477, T0471, T0472, T0460, T0459, T0447, T0446, T0435, T0436, T0427, T0426, T0424, T0425, T0421, T0422, T0423, T0420, T0406, T0404, T0405, T0399, T0398, T0396, T0382, T0377, T0376, T0344, T0343, T0338, T0337, T0336, T0334, T0335, T0332, T0331, T0320, T0323, T0321, T0322, T0316, T0309, T0310, T0292, T0291, T0289, T0290, T0288, T0287, T0280, T0279, T0277, T0276, T0265, T0264, T0256, T0255, T0241, T0244, T0242, T0243, T0239, T0240, T0232, T0231, T0226, T0227, T0228, T0229, T0230, T0225, T0221, T0220, T0217, T0218, T0208, T0209, T0207, T0206, T0200, T0199, T0194, T0195, T0191, T0190, T0185, T0186, T0183, T0184, T0176, T0177, T0174, T0175, T0169, T0168, T0164, T0165, T0159, T0160, T0147, T0148, T0140, T0139, T0124, T0122, T0121, T0120, T0114, T0113, T0110, T0109, T0108, T0107, T0105, T0106, T0098, T0097, T0096, T0095, T0090, T0089, T0087, T0088, T0085, T0086, T0083, T0082, T0076, T0077, T0046, T0047, T0048, T0049, T0039, T0038, T0007, T0004, A7229, A7230, A7221, A7222, A7209, A7210, A7208, A7207, A7200, A7199, A7191, A7192, A7190, A7189, A7177, A7178, A7151, A7152, A7146, A7147, A7144, A7142, A7140, A7141, A7131, A7130, A7128, A7129, A7107, A7108, A7109, A7098, A7099, A7097, A7095, A7092, A7096, A7094, A7093, A7090, A7089, A7087, A7086, A7080, A7081, A7055, A7056, A7057, A7058, A7059, A7060, A7054, A7051, A7050, A7047, A7041, A7023, A7024, A6997, A6996, X6979, A6973, A6974, A6959, A6954, A6955, A6947, A6946, A6939, A6938, A6936, A6937, A6935, A6934, X6924, A6922, A6921, A6919, A6920, A6909, A6910, A6905, A6904, A6895, A6894, A6888, A6887, A6882, A6881, A6874, A6875, A6877, A6876, A6869, A6868, A6862, A6863, A6859, A6858, A6851, A6850, A6841, A6842, X6837, A6803, A6804, A6805, A6806, A6784, A6783, A6763, A6764, A6765, A6766, A6760, A6759, A6728, A6724, A6725, A6703, A6704, A6683, A6684, A6674, A6675, A6652, A6651, A6639, A6638, A6636, A6637, A2140, A2139, A2134, A2135, A2125, A2126, A2112, A2111, A2085, A2084, A2056, A2057, A2052, A2051, A2046, A2047, A2032, A2031, A2028, A2027, A2014, A2015, A2004, A2005, A1995, A1996, A1993, A1992, A1980, A1981, A1970, A1969, A1963, A1964, A1958, A1957, A1952, A1953, A1940, A1941, A1938, A1939, A1931, A1932, A1921, A1920, A1918, A1919, A1917, A1916, A1913, A1914, A1907, A1908, A1904, A1903, A1900, A1899, A1888, A1887, A1882, A1881, A1868, A1867, A1862, A1863, A1859, A1860, A1856, A1855, A1850, A1851, A1852, A1849, A1842, A1843, A1840, A1841, A1835, A1836, A1827, A1826, A1814, A1815, A1805, A1806, A1796, A1795, A1790, A1787, A1788, A1789, A1783, A1784, A1777, A1778, A1770, A1771, A1751, A1752, A1744, A1745, A1743, A1742, A1740, A1741, A1737, A1736, A1709, A1708, A1705, A1702, A1703, A1704, A1697, A1698, A1699, A1696, A1676, A1677, A1671, A1670, A1660, A1661, A1662, A1659, A1641, A1642, A1638, A1637, A1631, A1630, A1622, A1623, A1624, A1625, A1608, A1609, A1598, A1597, A1594, A1595, A1584, A1585, A1571, A1570, A1557, A1558, A1542, A1543, A1536, A1537, A1503, A1504, A1493, A1494, A1491, A1492, A1470, A1469, A1468, A1467, A1462, A1463, A1452, A1453, A1445, A1446, A1431, A1432, A1426, A1425, A1414, A1415, A1406, A1407, A1397, A1398, A1390, A1389, A1388, A1387, A1385, A1386, A1384, A1383, A1381, A1380, A1375, A1376, A1372, A1371, A1365, A1366, A1361, A1362, A1359, A1360, A1358, A1357, A1355, A1354, A1352, A1353, A1351, A1350, A1346, A1345, A1338, A1339, A1333, A1332, A1331, A1330, A1315, A1316, A1289, A1290, A1269, A1270, A1266, A1267, A1258, A1259, A1247, A1246, A1243, A1244, A1228, A1229, A1215, A1214

Distribution pattern

Nationwide

device · product 2 of 37

IceFORCE" 2.1 CX Cryoablation Needle

Z-0658-2021

Recall number: Z-0658-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3604 UDIs: 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027 Batch Numbers: U0903, U0785, U0617, U0042, T0166, T0156, A7083, A6931, A6928, A6916, A6734, A1549, A1527, X1483, A1203

Distribution pattern

Nationwide

device · product 3 of 37

IceFORCE" 2.1 CX L 90¿ Cryoablation Needle

Z-0659-2021

Recall number: Z-0659-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 740 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3618 UDIs: 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089 Batch Numbers: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189

Distribution pattern

Nationwide

device · product 4 of 37

IcePearl" 2.1 CX 90¿ Cryoablation Needle

Z-0660-2021

Recall number: Z-0660-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 8453 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3601 UDIs: 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990 Batch Numbers: U1391, U1389, U1387, U1390, U1388, U1386, U1272, U1337, U1336, U1270, U1268, U1265, U1266, U1267, U1271, U1269, U1240, U1235, U1237, U1238, U1233, U1236, U1239, U1234, U1130, U1129, U1094, U1093, U1075, U1074, U1071, U1054, U0990, U0985, U0984, U0983, U0986, U0987, U0989, U0988, U0887, U0883, U0881, U0879, U0877, U0874, U0876, U0880, U0882, U0888, U0889, U0886, U0875, U0878, U0830, U0832, U0833, U0834, U0835, U0836, U0837, U0831, U0822, U0819, U0816, U0811, U0812, U0813, U0815, U0818, U0821, U0814, U0817, U0820, U0782, U0783, U0777, U0776, U0774, U0775, U0771, U0744, U0742, U0740, U0746, U0745, U0743, U0741, U0734, U0735, U0733, U0736, U0731, U0732, U0702, U0700, U0699, U0701, U0703, U0704, U0706, U0705, U0687, U0659, U0653, U0686, U0624, U0655, U0658, U0625, U0656, U0657, U0651, U0654, U0652, U0650, U0623, U0621, U0619, U0593, U0618, U0647, U0622, U0620, U0648, U0596, U0594, U0591, U0563, U0592, U0561, U0559, U0564, U0562, U0560, U0539, U0537, U0536, U0538, U0534, U0535, U0533, U0531, U0529, U0527, U0532, U0526, U0475, U0530, U0528, U0476, U0474, U0500, U0499, U0477, U0479, U0473, U0478, U0422, U0421, U0377, U0376, U0305, U0304, X0232, U0185, U0186, U0135, U0133, U0132, U0130, U0134, U0131, U0113, U0112, U0075, U0073, U0092, U0091, U0071, U0070, U0074, U0072, U0020, U0019, T0806, T0805, T0804, T0807, T0784, T0772, T0768, T0778, T0779, T0777, T0764, T0762, T0763, T0771, T0769, T0770, T0773, T0767, T0707, T0705, T0696, T0706, T0607, T0621, T0606, T0620, T0610, T0611, T0608, T0609, T0590, T0556, T0555, T0537, T0538, T0522, T0523, T0475, T0476, T0410, T0409, T0408, T0407, T0380, T0381, T0345, T0346, T0324, T0325, T0297, T0295, T0296, T0293, T0267, T0266, T0249, T0250, T0252, T0253, T0251, T0254, T0245, T0246, T0234, T0233, T0213, T0214, T0202, T0187, T0182, T0132, T0133, T0130, T0131, T0078, T0079, T0067, T0066, T0062, T0061, T0041, T0040, T0032, T0033, A7193, A7194, A7187, A7186, A7182, A7181, A7175, A7176, A7172, A7173, A7164, A7163, A7161, A7162, A7136, A7137, A7125, A7124, A7111, A7112, A7102, A7101, A7077, A7076, A7067, A7068, A6984, A6985, A6940, A6941, A6885, A6884, A6880, A6879, A6865, A6866, A6852, A6853, A6844, A6845, A6821, A6822, A6795, A6794, A6749, A6750, A6733, A6716, A6717, A6655, A6656, A2107, A2108, A2058, A2059, A2038, A2039, A1982, A1983, A1971, A1972, A1929, A1930, A1926, A1927, A1922, A1923, A1912, A1911, A1893, A1894, A1886, A1885, A1870, A1869, A1854, A1853, A1829, A1828, A1810, A1809, A1797, A1798, A1773, A1772, A1750, A1749, A1734, A1735, A1686, A1687, A1680, A1681, A1674, A1675, A1666, A1665, A1651, A1652, A1649, A1650, A1619, A1617, A1618, A1606, A1603, A1604, A1599, A1600, A1581, A1580, A1553, A1554, A1547, A1546, A1541, A1540, A1538, A1539, A1523, A1520, A1517, A1516, A1509, A1510, A1500, A1499, X1482, A1455, A1454, A1440, A1441, A1438, A1439, A1417, A1418, A1408, A1409, A1394, A1393, A1370, A1369, A1349, A1348, A1344, A1343, A1303, A1302, A1299, A1300, A1296, A1297, A1272, A1271, A1268, A1233, A1232, A1223, A1224, A1204, A1205, A1190, A1191, A1169, A1168, A1156, A1155

Distribution pattern

Nationwide

device · product 5 of 37

IcePearl" 2.1 CX Cryoablation Needle

Z-0661-2021

Recall number: Z-0661-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 86 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3603 UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010 Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249

Distribution pattern

Nationwide

device · product 6 of 37

IcePearl" 2.1 CX L 90¿ Cryoablation Needle

Z-0662-2021

Recall number: Z-0662-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 261 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3617 UDIs: 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072, 7290104831072 Batch numbers: U1310, U1309, U1306, U1305, X0828, U0727, U0728, U0641, U0640, U0587, U0586, U0585, U0084, A7113, A6977, A6963, A6962, A6681, A6682, A1657, A1522, A1178, A1177

Distribution pattern

Nationwide

device · product 7 of 37

IceRod" 1.5 CX 90¿ Cryoablation Needle¿

Z-0663-2021

Recall number: Z-0663-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 18,731 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3533 UDIs: 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587, 7290104830587 Batch Numbers: U1450, U1445, U1437, U1436, U1419, U1415, U1413, U1411, U1412, U1414, U1417, U1418, U1416, U1408, U1410, U1409, U1405, U1382, U1377, U1379, U1381, U1384, U1385, U1383, U1373, U1376, U1375, U1380, U1378, U1374, U1366, U1323, U1321, U1314, U1317, U1318, U1320, U1322, U1324, U1315, U1316, U1319, U1313, U1172, U1168, U1126, U1169, U1170, U1171, U1173, U1167, U1124, U1120, U1087, U1085, U1119, U1122, U1125, U1086, U1123, U1121, U1083, U1078, U1079, U1080, U1082, U1081, U1084, U1076, U1077, U1049, U1045, U1044, U1046, U1047, U1048, U0973, U0969, U0967, U0970, U0972, U0968, U0971, U0966, U0960, U0915, U0866, U0913, U0914, U0867, U0692, U0691, U0689, U0690, U0515, U0512, U0510, U0513, U0514, U0511, U0507, U0469, U0466, U0504, U0463, U0465, U0468, U0467, U0464, U0388, U0386, U0350, U0387, U0349, U0348, U0347, U0343, U0339, U0340, U0342, U0344, U0345, U0346, U0338, U0341, U0254, U0252, U0250, U0247, U0249, U0251, U0253, U0248, U0237, U0238, U0235, U0236, U0233, U0234, X0231, U0197, U0200, U0201, U0204, U0205, U0198, U0196, U0199, U0202, U0195, U0173, U0172, U0166, U0165, U0117, U0115, U0116, U0118, U0119, U0120, U0109, U0108, U0102, U0103, U0095, U0094, U0066, U0064, U0065, U0067, U0068, U0069, U0045, U0014, U0028, U0012, U0013, U0010, U0011, T0757, T0753, T0750, T0751, T0756, T0754, T0752, T0755, T0698, T0691, T0689, T0700, T0701, T0699, T0690, T0692, X0724, T0723, T0721, T0722, T0720, T0679, T0680, T0681, T0676, T0677, T0668, T0669, T0660, T0659, T0647, T0648, T0616, T0618, T0619, T0617, T0614, T0615, T0599, T0605, T0597, T0598, T0596, T0595, T0571, T0572, T0566, T0565, T0560, T0559, T0557, T0558, T0542, T0541, T0539, T0540, T0536, T0527, T0528, T0511, T0512, T0503, T0504, T0488, T0489, T0491, T0492, T0493, T0490, T0474, T0473, T0469, T0468, T0466, T0467, T0454, T0432, T0418, T0419, T0415, T0414, T0412, T0411, T0397, T0386, T0385, T0384, T0383, T0359, T0358, T0356, T0355, T0329, T0330, T0318, T0315, T0312, T0311, T0286, T0285, T0257, T0258, T0173, T0172, T0170, T0171, T0149, T0150, T0119, T0118, T0092, T0091, T0075, T0036, T0037, T0031, T0029, T0030, T0028, T0026, T0027, T0022, T0021, T0019, T0020, T0016, T0017, T0014, T0013, T0012, T0011, T0009, T0010, T0002, T0003, A7211, A7165, A7166, A7159, A7158, A7139, A7138, A7119, A7120, A7116, A7115, A7070, A7071, A7066, A7065, A7063, A7064, A7053, A7052, A7048, A7049, A7042, A7043, A7038, A7039, A7036, A7037, A7031, A7030, A7020, A7019, A7016, A7017, A7002, A7003, A6992, A6988, A6989, A6990, A6991, A6975, A6960, A6961, A6957, A6958, A6945, A6944, A6906, A6907, A6902, A6903, A6897, A6896, A6892, A6891, A6889, A6847, A6846, A6838, A6839, A6830, A6833, A6831, A6832, A6816, A6817, A6818, A6815, A6801, A6802, A6800, A6799, A6798, A6797, A6791, A6790, A6780, A6776, A6779, A6769, A6770, A6753, A6752, A6741, A6742, A6731, A6726, A6727, A6721, A6722, A6706, A6705, A6668, A6667, A6659, A6660, A6650, A6649, A6644, A6645, A6640, A6641, A6635, A6634, A2137, A2136, A2131, A2132, A2123, A2122, A2120, A2119, A2109, A2110, A2106, A2105, A2103, A2104, A2095, A2096, A2092, A2091, A2086, A2087, A2063, A2061, A2060, A2054, A2055, A2044, A2045, A2041, A2042, A2035, A2034, A2020, A2021, A2003, A2002, A1978, A1979, A1962, A1961, A1960, A1959, A1956, A1955, A1950, A1951, A1946, A1947, A1934, A1935, A1905, A1906, A1901, A1902, A1895, A1896, A1878, A1879, A1880, A1877, A1871, A1872, A1864, A1865, A1799, A1800, A1791, A1792, A1754, A1755, A1746, A1747, A1706, A1707, A1700, A1701, A1693, A1692, A1682, A1683, A1678, A1679, A1672, A1673, A1667, A1668, A1654, A1653, A1640, A1639, A1627, A1628, A1620, A1621, A1614, A1613, A1610, A1611, A1590, A1589, A1578, A1579, A1514, A1515, A1513, A1512, A1506, A1507, A1472, A1471, A1449, A1448, A1434, A1433, A1421, A1422, A1413, A1412, A1336, A1337, A1306, A1307, A1304, A1305, A1262, A1263, A1260, A1261, A1253, A1254, A1256, A1255, A1221, A1222, A1217, A1216, A1176, A1175, A1174, A1167, A1166, A1163, A1162, B8940

Distribution pattern

Nationwide

device · product 8 of 37

IceSphere" 1.5 CX 90¿ Cryoablation Needle

Z-0664-2021

Recall number: Z-0664-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 6,363 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3573 UDIs: 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133, 7290104831133 Batch Numbers: U1458, U1457, U1459, U1460, U1461, U1429, U1428, U1426, U1427, U1425, U1430, U1333, U1331, U1232, U1230, U1334, U1332, U1335, U1330, U1229, U1231, U1222, U1221, U1219, U1220, U1184, U1182, U1180, U1179, U1183, U1181, U1162, U1161, U1160, U0982, U0981, U0977, U0980, U0922, U0923, U0920, U0921, U0872, U0870, U0871, U0873, U0519, U0518, U0508, U0303, U0300, U0301, U0302, U0472, U0299, U0298, U0262, U0260, U0259, U0257, U0258, U0261, U0239, U0240, U0219, X0230, U0220, U0207, U0193, U0184, U0168, U0169, U0167, U0125, U0124, U0126, U0127, U0128, U0099, U0098, U0058, U0059, U0057, U0052, U0051, U0018, U0017, T0802, T0828, T0829, T0803, T0820, T0798, T0800, T0799, T0780, T0704, T0694, T0695, T0703, T0682, T0683, T0671, T0670, T0655, T0656, T0658, T0657, T0653, T0654, T0593, T0594, T0583, T0584, T0577, T0578, T0567, T0458, T0455, T0456, T0379, T0378, T0366, T0367, T0350, T0349, T0326, T0327, T0308, T0307, T0301, T0302, T0205, T0204, T0102, T0101, T0093, T0094, T0080, T0081, T0072, T0073, A7127, A7126, A7117, A7118, A7104, A7103, A7079, A7078, A6998, A6999, X6978, A6965, A6964, A6949, A6948, A6932, A6933, A6870, A6871, A6860, A6861, A6854, A6855, A6786, A6785, A6767, A6768, A6756, A6755, A6745, A6746, A6691, A6690, A6680, A6679, A6670, A6669, A6642, A6643, A6632, A6633, A1977, A1976, A1973, A1974, A1966, A1967, A1780, A1779, A1762, A1763, A1465, A1466, A1443, A1442, A1428, A1427, A1395, A1396, A1275, A1274, A1181, A1182

Distribution pattern

Nationwide

device · product 9 of 37

IceRod" 1.5 i-Thaw" Cryoablation Needle

Z-0665-2021

Recall number: Z-0665-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 262 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR4009 UDIs: 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204, 7290104830204 Batch Numbers: U1362, U1217, U0957, U0283, U0282, U0087, T0819, T0392, A6883, A6657, A2043, A1954, A1669, A1532, A1501, A1476, A1329

Distribution pattern

Nationwide

device · product 10 of 37

IceRod" 1.5 PLUS 90¿ Cryoablation Needle

Z-0666-2021

Recall number: Z-0666-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 4,645 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3508 UDIs: 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563 Batch Numbers: U1442, U1443, U1435, U1434, U1371, U1372, U1360, U1361, U1020, U1038, U1019, U1017, U1018, U0436, U0392, U0373, U0372, U0327, U0333, U0336, U0334, U0335, U0332, U0329, U0330, U0294, U0289, U0291, U0292, U0290, U0293, U0212, U0213, U0061, U0063, U0044, U0043, U0006, U0007, T0499, T0498, T0342, T0340, T0341, T0328, T0314, T0300, T0298, T0299, T0115, T0116, T0111, T0112, T0068, T0069, T0052, T0053, T0034, T0035, A7228, A7227, A7185, A7184, A7169, A7170, A7171, A7168, A7132, A7133, A7123, A7028, A7029, A7000, A7001, A6971, A6970, A6950, A6951, A6792, A6793, A6778, A6777, A6771, A6772, A6736, A6735, A6699, A6700, A6692, A6693, A6685, A6686, A6665, A6666, A6662, A6661, A6653, A6654, A2115, A2114, A2098, A2097, A2048, A2022, A2009, A2007, A2008, A2006, A1997, A1985, A1984, A1898, A1897, A1830, A1831, A1821, A1822, A1816, A1817, A1808, A1807, A1663, A1664, A1655, A1656, A1593, A1480, A1481, A1456, A1457, A1450, A1451, A1410, A1411, A1367, A1239, A1240, A1237, A1238, A1212, A1213

Distribution pattern

Nationwide

device · product 11 of 37

IceRod" 1.5 PLUS Cryoablation Needle

Z-0667-2021

Recall number: Z-0667-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 255 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3510 UDIs: 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570, 7290104830570 Batch Numbers: U1021, U1022, U1014, U1013, U0780, U0781, U0391, U0214, U0008, A2081, A2080, A1531

Distribution pattern

Nationwide

device · product 12 of 37

IceRod" 1.5 90¿ Cryoablation Needle

Z-0668-2021

Recall number: Z-0668-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 93 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3204 UDIs: 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242, 7290104830242 Batch Numbers: U0495, U0498, U0496, U0497, U0420, A0902, A0903

Distribution pattern

Nationwide

device · product 13 of 37

IceRod" 1.5 Cryoablation Needle

Z-0669-2021

Recall number: Z-0669-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3203 UDIs: 07290104830198, 07290104830198, 07290104830198, 07290104830198 Batch Numbers: U0382, A6775, A1875, A0575

Distribution pattern

Nationwide

device · product 14 of 37

IceSphere" 1.5 90¿ Cryoablation Needle

Z-0670-2021

Recall number: Z-0670-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 2,429 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3560 UDIs: 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945 Batch Numbers: U1454, U1455, U1456, U1420, U1421, U1325, U1326, U1328, U1327, U0435, U0432, U0369, U0351, U0352, T0403, T0402, T0395, T0394, T0305, T0146, T0126, T0006, T0023, T0024, T0018, T0015, A7205, A6966, A6967, A6969, A6968, A6943, A6942, A6917, A6918, A2089, A2090, A1858, A1857, A1848, A1847, A1823, A1824, A1819, A1818, A1811, A1812, A1801, A1802, A1794, A1793, A1785, A1786, A1601, A1602, A1591, A1592, A1489, A1490, A1477, A1478, A1309, A1308, A1294, A1295, A1293, A1292, A1265, A1264, A1250, A1251, A1242, A1241

Distribution pattern

Nationwide

device · product 15 of 37

IceSphere" 1.5 Cryoablation Needle

Z-0671-2021

Recall number: Z-0671-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 245 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3558 UDIs: 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938, 7290104830938 Batch numbers: U1403, U1218, U0295, U0215, U0182, U0153, U0047, T0674, T0463, T0129, A7010, A6956, A6893, A6738, A2102, A1185

Distribution pattern

Nationwide

device · product 16 of 37

IceSphere" 1.5 S 90¿ Cryoablation Needle

Z-0672-2021

Recall number: Z-0672-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 729 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3561 UDIs: 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556, 7290104830556 Batch Numbers: U1176, U1175, U0460, U0459, U0157, T0702, T0389, T0390, T0371, T0370, T0064, T0065, T0045, T0044, A7075, A7074, A6873, A6872, A1632, A1633, A1616, A1615, A1363, A1364

Distribution pattern

Nationwide

device · product 17 of 37

IceSphere" 1.5 90¿ Cryoablation Needle

Z-0673-2021

Recall number: Z-0673-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 92 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3260 UDIs: 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259 Batch Numbers: U0326, U0325, U0286, U0285, A7012, A7011

Distribution pattern

Nationwide

device · product 18 of 37

IceSphere" 1.5 Cryoablation Needle

Z-0674-2021

Recall number: Z-0674-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 39 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3258 UDI: 07290104830211 Batch Number: A0125

Distribution pattern

Nationwide

device · product 19 of 37

IceSeed" 1.5 90¿ Cryoablation Needle

Z-0675-2021

Recall number: Z-0675-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 788 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3202 UDIs: 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235, 7290104830235 Batch Numbers: U1165, U1166, U0911, U0912, U0397, U0381, U0368, T0791, T0790, T0465, T0464, T0050, T0051, A6981, A6980, A2129, A2128, A1635, A1636, A1528, A1392, A1391, A0944, A0943, A0408, A0407, A0284

Distribution pattern

Nationwide

device · product 20 of 37

IceSeed" 1.5 Cryoablation Needle

Z-0676-2021

Recall number: Z-0676-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 152 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3201 UDIs: 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181, 7290104830181 Batch Numbers: U0181, T0393, A6912, A6664, A1915, A1072, A1024, A0853, A0574

Distribution pattern

Nationwide

device · product 21 of 37

IceEDGE" 2.4¿ 90p¿ Cryoablation Needle

Z-0677-2021

Recall number: Z-0677-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 525 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3506 UDIs: 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594, 7290104830594 Batch Numbers: U0288, U0287, U0062, U0060, T0433, T0434, T0416, T0417, X6836, A6781, A6782, A6762, A6761, A2078, A2079, A1529, A1373, A1374

Distribution pattern

Nationwide

device · product 22 of 37

IceRod" 1.5 MRI 90¿ Cryoablation Needle¿

Z-0678-2021

Recall number: Z-0678-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 3,894 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3195 UDIs: 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297 Batch Numbers: U1406, U1407, U1370, U1369, U1041, U1042, U0611, U0610, U0501, U0419, U0447, U0444, U0418, U0322, U0323, U0211, U0243, U0244, U0208, U0209, U0210, U0189, U0188, U0175, U0174, U0031, U0164, U0005, U0004, U0002, U0001, T0786, T0785, T0664, T0665, T0649, T0650, T0562, T0561, T0452, T0451, T0445, T0441, T0440, T0364, T0365, T0361, T0360, T0192, T0193, T0179, T0180, A7213, A6715, A6714, A6712, A6711, A6672, A6673, A2093, A2094, A2036, A2037, A2023, A2024, A2011, A2012, A1986, A1987, A1949, A1948, A1944, A1943, A1925, A1924, A1884, A1883, A1839, A1837, A1838, A1832, A1833, A1758, A1759, A1756, A1757, A1648, A1647, A1572, A1573, A1555, A1556, A1534, A1334, A1321, A1322, A1318, A1319, A1200, A1198, A1201, A1199, A1070, A1071, A1068, A1067, A1002, A1001, A0882, A0883, A0878, A0879, A0737, A0738

Distribution pattern

Nationwide

device · product 23 of 37

IceRod" 1.5 MRI Cryoablation Needle¿

Z-0679-2021

Recall number: Z-0679-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 772 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3193 UDIs: 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273, 7290104830273 Batch Numbers: U1440, U1441, U1311, U1312, U1015, U1016, U0462, U0461, U0050, U0030, T0520, T0521, T0157, T0158, A7135, A7134, A6987, A6986, A6707, A6708, A6689, A6688, A1730, A1731, A1149, A1150

Distribution pattern

Nationwide

device · product 24 of 37

IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿

Z-0680-2021

Recall number: Z-0680-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 1,526 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3194 UDIs: 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280 Batch Numbers: U1368, U1367, U1040, U0396, U0380, U0375, U0374, U0242, U0241, T0532, T0533, T0531, T0530, T0444, T0443, T0442, T0353, T0354, T0262, T0263, A6720, A6719, A6698, A6697, A2049, A2050, A1999, A1998, A1990, A1991, A1891, A1890, A1844, A1845, A1690, A1562, A1563, A1533, A1326, A1325, A1197, A1196, A1041, A1040, A1008, A1007, A0955, A0954

Distribution pattern

Nationwide

device · product 25 of 37

IceSeed" 1.5 MRI Cryoablation Needle

Z-0681-2021

Recall number: Z-0681-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 627 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3192 UDIs: 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266 Batch Numbers: U1438, U1439, U0962, U0961, U0437, U0378, T0697, T0688, T0388, T0387, A7150, A7149, A2018, A2017, A1711, A1710, A1689, A1403, A1404, A0896, A0897

Distribution pattern

Nationwide

device · product 26 of 37

IceFORCE" 2.1 CX Prostate Cryoablation Kit

Z-0682-2021

Recall number: Z-0682-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 85 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3605 UDIs: 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034 Batch Numbers: U1030, U0904, U0864, U0856, U0763, U0649, T0153, A7062, A7061, A6930, A6758, A1781, A1776, A1565, A1550, A1435, A1291

Distribution pattern

Nationwide

device · product 27 of 37

IcePearl" 2.1 CX Prostate Cryoablation Kit

Z-0683-2021

Recall number: Z-0683-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 215 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3606 UDIs: 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041 Batch Numbers: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171

Distribution pattern

Nationwide

device · product 28 of 37

Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

Z-0684-2021

Recall number: Z-0684-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 140 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3607 UDIs: 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058, 7290104831058 Batch Numbers: U1302, U1303, U1301, U1032, U0616, U0590, U0589, U0583, U0540, U0363, U0318, U0083, T0552, T0163, T0154, A6915, A6849, A6848, A6757, A6754, A1782, A1569, A1567, A1436, A1298, A1194

Distribution pattern

Nationwide

device · product 29 of 37

Three IcePearl" 2.1 CX Prostate Cryoablation Kit

Z-0685-2021

Recall number: Z-0685-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 117 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3608 UDIs: 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065, 7290104831065 Batch Numbers: U1308, U1304, U1066, U1034, U0859, U0860, U0661, U0660, U0609, U0588, T0815, T0816, T0270, T0238, T0212, T0211, T0181, T0144, T0055, A7122, A7027, A7014, A6926, A6913, A6900, A6857, A6744, A6710, A1937, A1583, A1461

Distribution pattern

Nationwide

device · product 30 of 37

IceRod" i-Thaw" Prostate Cryoablation Kit

Z-0686-2021

Recall number: Z-0686-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 947 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3572 UDIs: 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983 Batch Numbers: U1423, U1422, U1329, U1227, U1091, U1128, U1127, U1090, U0976, U1011, U0919, U0917, U0868, U0869, U0738, U0739, U0403, U0404, U0297, U0296, U0256, U0255, U0217, U0218, U0034, U0176, U0033, U0032, U0016, U0040, U0015, T0759, T0758, T0731, T0651, T0634, T0524, T0507, T0502, T0470, T0429, T0401, T0391, T0372, T0351, T0319, T0306, T0281, T0271, T0247, T0198, T0189, T0161, T0084, T0074, T0008, A7231, A7212, A7206, A7188, A7040, A7018, A6983, A6898, A6886, A6878, A6867, A6864, A6843, A6824, A6787, A6718, A6687, A6671, A6663, A6646, A2138, A2124, A2100, A2099, A2082, A2053, A2013, A2001, A1994, A1975, A1945, A1892, A1761, A1748, A1688, A1685, A1612, A1596, A1519, A1502, A1497, A1479, A1447, A1424, A1405, A1378, A1377, A1356, A1347, A1340, A1320, A1227, A1218, A1202, A1187

Distribution pattern

Nationwide

device · product 31 of 37

IceSeed" Prostate Cryoablation Kit

Z-0687-2021

Recall number: Z-0687-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 52 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3008 UDIs: 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068, 7290104830068 Batch Numbers: T0783, T0686, T0719, T0678, A6713, A6676, A2130, A2075, A1813, A1695, A1684

Distribution pattern

Nationwide

device · product 32 of 37

IceRod" Prostate Cryoablation Kit

Z-0688-2021

Recall number: Z-0688-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 64 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3070 UDIs: 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082, 7290104830082 Batch Numbers: U0412, U0029, U0039, T0775, T0687, T0675, A1873, A1866, A1820, A1643, A1420, A1226

Distribution pattern

Nationwide

device · product 33 of 37

Five IceSphere" Prostate Cryoablation Kit

Z-0689-2021

Recall number: Z-0689-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 419 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3570 UDIs: 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969, 7290104830969 Batch Numbers: U1402, U1223, U1224, U1225, U1177, U1178, U1118, U1115, U1070, U1069, U0824, U0825, U0823, U0826, U0470, U0411, U0402, U0407, U0384, U0389, U0216, U0183, U0122, U0154, U0155, T0673, T0672, T0635, T0484, T0483, T0461, T0462, T0373, T0374, T0363, T0362, T0127, T0104, T0103, A7009, A6953, A6952, A6890, A6789, A6737, A2101, A2088, A1629, A1626, A1607, A1577, A1382, A1184

Distribution pattern

Nationwide

device · product 34 of 37

Five IceRod" i-Thaw" Prostate Cryoablation Kit

Z-0690-2021

Recall number: Z-0690-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 178 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR3571 UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976 Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252

Distribution pattern

Nationwide

device · product 35 of 37

IceRod" i-Thaw" Prostate Cryoablation Kit

Z-0691-2021

Recall number: Z-0691-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 243 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR4070 UDIs: 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105 Batch Numbers: U1363, U0865, U0555, U0542, U0151, U0150, U0054, U0053, U0046, U0037, U0036, T0633, T0515, T0430, T0274, T0273, T0201, T0188, T0167, A7174, A7100, A7044, A7022, A7021, A6788, A6740, A2117, A2019, A1968, A1753, A1605, A1535, A1430, A1429, A1235, U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225, G5063, G5871, G5900, G5902, G5975, P1901

Distribution pattern

Nationwide

device · product 36 of 37

IceSeed" Prostate Cryoablation Kit

Z-0692-2021

Recall number: Z-0692-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 211 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR4518 UDIs: 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075 Batch Numbers: U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225

Distribution pattern

Nationwide

device · product 37 of 37

IceRod" He-Thaw Prostate Cryoablation Kit

Z-0693-2021

Recall number: Z-0693-2021
Initiated: November 18, 2020
Classification: Class II
Status: Completed
Recalling firm: Boston Scientific Corporation
Quantity: 115 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaint trend regarding needle shaft gas leaks.

Code information

UPN: FPRPR4570 UDIs: 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099 Batch Numbers:G5063, G5871, G5900, G5902, G5975, P1901, P2150, P2204, P2206, P2207, P2240, P2241, P2242, P2243, P2245, P2247, P2249, P2251, P2253, P2254, P2256, P2258, P2259, P2261, P2262, P2263, P2268, P2272, P2274, P2404, P2405, P2406, P2411

Distribution pattern

Nationwide

Event summary

Source snapshots represented here

Every recalled product in this event

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information

Distribution pattern

Reason for recall

Code information