Abbott Recalls Selected Lots of PowerSail Coronary Dilatation Catheters

July 28, 2009—Abbott Vascular (Santa Clara, CA) announced that it as conducted a voluntary recall of three lots of the 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. The company stated that although 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, potentially leading to death. 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, the company stated.

According to the company, 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 postprocedural myocardial infarction. Subsequently, the patient was reported to be doing well.

Abbott advised that the PowerSail coronary dilatation catheter is distributed for prescription use only to approved United States and international healthcare organizations. Affected devices can be identified by the part number and lot number combinations: PowerSail 3.25 X 18 mm (US Product: 1005524-18; Lot: 7101051; Expiration: September 2009), PowerSail 4 X 8 mm (International Product: 1005726-08; Lot: 7112051; Expiration: October 2009), PowerSail 2.75 X 18 mm (US Product: 1005522-18; Lot: 8012151; December 2009), and PowerSail 3.25 X 8 mm (US Product: 1005524-08; Lot: 8053061; April 2010).

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 previously. Customers with questions or concerns should contact their Abbott Vascular representative or call the company at (800) 227-9902. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the US Food and Drug Administration's MedWatch program.