Recall Z-1302-2014— Biocardia, Inc.

Name: FDA recall Z-1302-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-03

Class II · Terminated

Class II FDA medical device recall by Biocardia, Inc., initiated 2014-03-03, terminated 2014-06-19. It names one FDA 510(k) clearance: K090999. Product: 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: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event..

Recalling firm: Biocardia, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-03
Terminated: 2014-06-19
Firm location: San Carlos, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K090999 — BIOCARDIA MORPH SHEATH GUIDEBiocardia, Inc.·cleared 2009-04-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.