A Class I recall has been issued for four lots of Powersail Coronary Dilatation Catheters made by Abbott Vascular. A Class I recall is the Food & Drug Administration’s (FDA) most serious type of recall, and is issued when a medical device could predictably cause serious health problems or death.
The recall involves three lots of Powersail Coronary Dilatation Catheters from United States distribution and one lot from international distribution. According to a notice posted on the FDA Website, Abbott has received 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 heart attack, which has the potential to lead to death.
According to a press release issued by Abbott Vascular, 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 heart attack. According to the release, the patient was reported to be doing well.
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:
Powersail 3.25×18mm (U.S.), Product# 1005524-18, Lot# 7101051,Exp. Date 09-2009
Powersail 4.0×8mm (CE), Product# 1005726-08, Lot# 7112051, Exp. Date 10-2009
Powersail 2.75×18mm (U.S.), Product# 1005522-18, Lot# 8012151, Exp. Date 12-2009
Powersail 3.25×8mm (U.S.), Product# 1005524-08, Lot# 8053061, Exp. Date 04-2010
According to the press release, 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.
Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.
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