Biocardia, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1302-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 3, 2014

Date Posted: April 2, 2014

Recall Number: Z-1302-2014

Event ID: 67712

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.

Status: Terminated

Product Quantity: ~2541 units - both catalog numbers.

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.

Voluntary or Mandated:

Voluntary: Firm initiated