MORPH ACCESSPRO Steerable Introducer…

Date

Feb. 26, 2014

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Biocardia, Inc.

Product

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.

Reason

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

Distribution pattern

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

Quantity

11 units

Codes and lots

Catalog number MAP690; Lot numbers 01162 and 01186.

Recall started

Feb. 7, 2014

Device type

Introducer, Catheter

Root cause (FDA)

Process control

What the company told customers

Sales Representative called each affected hospital on February 7, 2014, to notify them of the recall. BioCardia has initiated a recall of Morph AccessPro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Sales representatives contacted hospital sites identified in Attachment 3 by telephone. Script provided as follows: "BioCardia has initiated a recall of Morph Access Pro due to a potential compromise of the sterile barrier. Use of this product may result in patient infection. Our records indicate that we sold you. The recall is limited to these units in this lot sold to you. We would like to confirm if you still have the unit(s). If you do, we ask that you quarantine the unit(s) and our customer service department will contact you to coordinate the return of the unit(s)." For further questions please call (650) 226-0133.

Recall number

Z-0991-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0991-2014. The agency record governs; check it and the company before acting.