Home / Recalls / Biocardia, Inc. / Z-1302-2014

Z-1302-2014 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 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

Other recalls by Biocardia, Inc.

  • Z-1301-2014 Class II — Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Sing (March 3, 2014)
  • Z-0991-2014 Class II — MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Ste (February 7, 2014)