Biocardia, Inc. recalls Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlo

Recalled April 2, 2014 · FDA recall Z-1301-2014 · Biocardia

Hazard

Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. · FDA Class II

Units

~2541 - both models

Sold at

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

Description

Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.

Product

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.

Manufacturer(s)

Biocardia, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →