Biocardia, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1301-2014)

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, 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.

Product Classification:

Class II

Date Initiated: March 3, 2014

Date Posted: April 2, 2014

Recall Number: Z-1301-2014

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 - both models

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

Distribution Pattern:

Worldwide Distribution: US (nationwide) and country of: Israel.

Voluntary or Mandated:

Voluntary: Firm initiated