Z-1302-2014 Class II Terminated
FDA device recall Z-1302-2014 was initiated by Biocardia, Inc. on March 3, 2014 and is designated Class II. Reason for recall: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. The recall status is terminated (terminated June 19, 2014). Affected quantity: ~2541 units - both catalog numbers..
Recall Details
- Product Type
- Devices
- Report Date
- April 2, 2014
- Initiation Date
- March 3, 2014
- Termination Date
- June 19, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- ~2541 units - both catalog numbers.
Product Description
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.
Reason for Recall
Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
Distribution Pattern
Worldwide Distribution: US (nationwide) and country of: Israel.
Code Information
Catalog number MAP690 -lot numbers: 1051 1063 1083 1106 1119 1137 1138 1140 1146 1148 1151 1154 1160 1162 1183 1186