Home / Recalls / Biocardia, Inc. / Z-1301-2014

Z-1301-2014 Class II Terminated

Recalled by Biocardia, Inc. — San Carlos, CA

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 - both models

Product Description

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.

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 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