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U.S. Department of Health and Human Services

Safety

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POWERSAIL Coronary Dilatation Catheters

Audience: Cardiovascular surgery healthcare professionals, hospital risk managers, surgical service supervisory staff

Abbott and FDA notified healthcare professionals of the national Class 1 recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints that the distal shaft of the catheter exhibited damage. The damage may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

[08/06/2009 - Recall Notice - FDA]
[07/30/2009 - Press Release - Abbott]