Device product
Morph AccessPro Steerable Introducer; 6F Introducer, 90 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-1302-2014
Product summary
- Firm
- Biocardia, Inc.
- Event
- Event 67712
- Status
- Terminated
- Classification
- Class II
- Quantity
- ~2541 units - both catalog numbers.
- Official record key
device-enforcement:Z-1302-2014
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 MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186
Distribution pattern: Worldwide Distribution: US (nationwide) and country of: Israel.
Derived failure modes
-
Foreign material or chemical contamination
particulates