POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US) Part #1005522-18
FDA device recall Z-1806-2009 · posted 2009-07-29 · Terminated
Recall details
- Recalling firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MAF
- Quantity affected
- 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, S
- Date initiated
- 2009-06-17
- Date posted
- 2009-07-29
- Date terminated
- 2010-07-06
- Location
- Temecula, CA
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