Biocardia, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0991-2014)

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: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature.

Product Classification:

Class II

Date Initiated: February 7, 2014

Date Posted: February 26, 2014

Recall Number: Z-0991-2014

Event ID: 67492

Reason for Recall:

Tyvek packaging may be worn, causing loss of package integrity.

Status: Terminated

Product Quantity: 11 units

Code Information:

Catalog number MAP690; Lot numbers 01162 and 01186.

Distribution Pattern:

US Distribution including the states of FL, MA, WY. OH, MI and KS.

Voluntary or Mandated:

Voluntary: Firm initiated