VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the following: (1) Balloon dilatation

FDA device recall Z-0939-2009 · posted 2009-02-03 · Terminated

Recall details

Recalling firm

Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Reason for recall

The recall was initiated after Abbott Vascular received reports that, in a small percentage of cases, 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 th

Action taken

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.

Root cause

Package design/selection

Status

Terminated

Product code

LOX

Quantity affected

126 units

Distribution

Worldwide Distribution.

Date initiated

2008-11-05

Date posted

2009-02-03

Date terminated

2012-08-13

Location

Temecula, CA