Recall -- Firm Press Release
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Abbott Issues Voluntary Recall of POWERSAIL® Coronary Dilatation Catheters
FOR IMMEDIATE RELEASE - ABBOTT PARK, Ill. - July 28, 2009 - Abbott has conducted a voluntary 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 (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it 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.
Abbott Vascular's sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the part numbers and lot numbers listed below. All outstanding units are in the company's possession or are in transit. Patients who have already been treated are not affected by this action.
|Product Designation||Product Number||Lot|
|POWERSAIL® 3.25x18mm (U.S.)|
|POWERSAIL® 4.0x8mm (CE)|
|POWERSAIL® 2.75x18mm (U.S.)|
|POWERSAIL® 3.25x8mm (U.S.)|
Three out of the four complaints of distal shaft damage resulted in no adverse patient effects. One complaint reported that the patient had evidence of a post-procedural myocardial infarction. Subsequently, the patient was reported to be doing well.
The United States Food and Drug Administration (FDA) has been apprised of this action, and it has classified this action as a Class I recall.
The POWERSAIL Coronary Dilatation Catheter is distributed for prescription use only to approved U.S. and international health care organizations. Affected devices can be identified by the part number and lot number combinations shown above.
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 Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.