Recall Z-0938-2009
Abbott Vascular-Cardiac Therapies dba Guidant Corporation · initiated November 5, 2008
Product
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.
Codes / lots: Part Number: 1011759-08, Lot Numbers: 8050961 and 8062361.
Reason for recall
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
FDA-determined cause: Package design/selection
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.
Details
- Recall number
- Z-0938-2009
- Initiated
- November 5, 2008
- Posted by FDA
- February 3, 2009
- Terminated
- August 13, 2012
- Product code
- MAF – Stent, Coronary
- Quantity
- 98 units
- Distribution
- Worldwide Distribution.
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation, Temecula, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0939-2009 | VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 mm. The device is used for in the…The recall was initiated after Abbott Vascular received reports that, in a small percentage of cases, the… | 11/05/2008Terminated |