| Class 1 Device Recall POWERSAIL | |
Date Initiated by Firm | June 17, 2009 |
Date Posted | July 29, 2009 |
Recall Status1 |
Terminated 3 on July 06, 2010 |
Recall Number | Z-1807-2009 |
Recall Event ID |
52705 |
PMA Number | P810046 |
Product Classification |
Coronary Dilatation Catheter - Product Code MAF
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Product | POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US)
Part #1005524-08 |
Code Information |
Lot 8053061(exp 04-2010) |
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 |
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. |
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
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