Device product

Three IceFORCE" 2.1 CX Prostate Cryoablation Kit

Z-0684-2021

November 18, 2020

Class II

Product summary

Firm: Boston Scientific Corporation
Event: Event 86777
Status: Completed
Classification: Class II
Quantity: 140 units
Official record key: device-enforcement:Z-0684-2021

Official wording

Reason: 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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Complaint trend regarding needle shaft gas leaks.