Class 1 recall issued for Abbott's Powersail coronary dilation catheter

The FDA and Abbott Vascular have issued a national Class 1 recall of three lots of Powersail coronary dilatation catheters from U.S. distribution, as well as 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 MI, which has the potential to lead to death, according to the company and agency.

The Abbott Park, Ill.-based Abbott said that its sales representatives contacted all customers affected by the 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. The company also noted that patients who have already been treated are not affected by this action. 

Three out of the four complaints of distal shaft damage resulted in no adverse patient effects, Abbott reported. However, one complaint reported that the patient had evidence of a post-procedural MI.

The affected products are:

• Powersail 3.25x18mm (U.S.): Lot number, 7101051/Product number, 1005524-18
• Powersail 2.75x18mm (U.S.): Lot number, 8012151/Product number, 1005522-18
• Powersail 3.25x8mm (U.S.): Lot number, 8053061/Product number, 1005524-08
• Powersail 4.0x8mm (EU): Lot number, 7112051/Product number, 1005726-08

The Powersail catheters are distributed for prescription use only to approved U.S. and international healthcare organizations.