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U.S. Department of Health and Human Services

Class 2 Device Recall VOYAGER NC Coronary Dilatation Catheter

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  Class 2 Device Recall VOYAGER NC Coronary Dilatation Catheter see related information
Date Initiated by Firm November 05, 2008
Date Posted February 03, 2009
Recall Status1 Terminated 3 on August 13, 2012
Recall Number Z-0939-2009
Recall Event ID 50192
PMA Number P810046S226 
Product Classification Stent, coronary - Product Code LOX
Product VOYAGER NC Coronary Dilatation Catheter, 4.5 X 12.0 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.
Code Information Part Number: 1011759-12, Lot Numbers: 8041051, 8050561, 8061961 and Part Number: 1011750-12, Lot Number 8100761. 
Recalling Firm/
Manufacturer		 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact
951-914-2400
Manufacturer 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
FDA Determined
Cause 2		 Package design/selection
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.
Quantity in Commerce 126 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LOX and Original Applicant = ADVANCED CARDIOVASCULAR SYSTEMS, INC.
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