Device product
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature.
Z-1301-2014
Product summary
- Firm
- Biocardia, Inc.
- Event
- Event 67712
- Status
- Terminated
- Classification
- Class II
- Quantity
- ~2541 - both models
- Official record key
device-enforcement:Z-1301-2014
Official wording
Reason: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Code information: Catalog number MAP645 - Lot numbers: 1037 1048 1055 1059 1069 1073 1074 1079 1092 1095 1115 1118 1121 1125 1128 1130 1134 1147 1155 1164 1168 1169 1173 1177 1184 1190
Distribution pattern: Worldwide Distribution: US (nationwide) and country of: Israel.
Derived failure modes
-
Foreign material or chemical contamination
particulates