Recall Z-1807-2009 ยท MAF Stent, Coronary
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US) Part #1005524-08
| Date | Jul 29, 2009 (initiated Jun 17, 2009) |
| Status | Terminated |
| Reason | Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.