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Class 1 Device Recall POWERSAIL |
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Date Initiated by Firm |
June 17, 2009 |
Date Posted |
July 29, 2009 |
Recall Status1 |
Terminated 3 on July 06, 2010 |
Recall Number |
Z-1805-2009 |
Recall Event ID |
52705 |
PMA Number |
P810046 |
Product Classification |
Coronary Dilatation Catheter - Product Code MAF
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Product |
POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE) Part #1005726-08 |
Code Information |
Lot 7112051(exp 10-2009) |
Recalling Firm/ Manufacturer |
Abbott Vascular-Cardiac Therapies dba Guidant Corporation 26531 Ynez Rd Temecula CA 92591-4630
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For Additional Information Contact |
951-914-2400
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Manufacturer Reason for Recall |
Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.
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FDA Determined Cause 2 |
Process control |
Action |
Abbott Vascular sent an Urgent Device Recall letter (w/return form) to customers on June 17, 2009 requesting return of identified products to Abbott Vascular Territory Manager. Abbott Vascular issued a press release dated July 28, 2009. |
Quantity in Commerce |
557 total devices |
Distribution |
Worldwide: United States, Australia, Belguim, Canada, China, Czech Republic, France, Germany, Greece, India, Italy, Japan, Jordan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Spain, Sri Lanka, Switzerland, Thailand, and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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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.
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PMA Database |
PMAs with Product Code = MAF and Original Applicant = ADVANCED CARDIOVASCULAR SYSTEMS, INC.
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