FDA Recall Terminated

VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm. The device is used for in the following: (1) Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, (2) Balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, and (3) Balloon dilatation of a stent after implantation.

Recall: Z-0938-2009 · Initiated November 5, 2008

Recall

Recall Number: Z-0938-2009
Event Number: 50192
Firm: Abbott Vascular-Cardiac Therapies dba Guidant Corporation
FEI Number: 2024168
Product Code: MAF
Status: Terminated
Root Cause: Package design/selection
Initiated: November 5, 2008
Posted: February 3, 2009
Terminated: August 13, 2012
Address: 26531 Ynez Rd, Temecula, CA, 92591-4630

Description

Reason

The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the

Action

An Urgent Device Recall letter (dated November 6, 2008) with an Efficacy Check Reconciliation form was issued and hand-carried to affected customers by their respective Sales Representative who assisted in locating and returning the recalled units. The letter described the problem and informed customers that Abbott Vascular will replace returned recalled product with like product or with VOYAGER NC sizes when they become available. Additionally, customers were instructed to contact their Abbott Vascular local account representative to review their inventory, complete and return the attached Efficacy Check Reconciliation Form and return affected products to Abbott Vascular.

Distribution

Worldwide Distribution.

Quantity

98 units