Abbott Vascular issued a voluntary recall of four lots of its Powersail coronary dilation catheter after it received reports of damaged distal shafts.
Three of the four complaints, one for each lot, did not involve what the company called “adverse patient effects.” However, one complaint showed evidence that the patient suffered a post-procedure heart attack, but was subsequently said to be “doing well,” according to a press release.
Abbott spokesman Jonathon Hamilton told MassDevice that the total number of catheters in all four lots numbers about 550.
“Most of them had already been successfully used and all the outstanding products that hadn’t been used are accounted for,” Hamilton said, adding that Abbott initiated the recall several weeks ago.
The defect in the lots affected by the recall — three in the U.S. and one distributed internationally — can be detected and avoided before the catheters are used, but if undetected might cause contrast material to leak. That, in turn, could lead to “catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death,” according to the press release.
Sales reps for the Abbott Park, Ill.-based company have already contacted all customers affected by the recall and all units are either back in Abbott’s hands or on their way. Patients who have already been treated using the Powersail catheter are not affected by the recall.
The Food & Drug Administration labeled the action as a Class I recall, its highest recall level, indicating that the product in question could seriously injure or kill people.
The affected lots are as follows:
| Product Designation | Product Number | Lot Number |
Expiration Date |
|---|---|---|---|
| POWERSAIL® 3.25x18mm (U.S.) |
1005524-18 |
7101051 |
09-2009 |
| POWERSAIL® 4.0x8mm (CE) |
1005726-08 |
7112051 |
10-2009 |
| POWERSAIL® 2.75x18mm (U.S.) |
1005522-18 |
8012151 |
12-2009 |
| POWERSAIL® 3.25x8mm (U.S.) |
1005524-08 |
8053061 |
04-2010 |
Concerned customers should call their Abbott Vascular rep or the company at 1-800-227-9902; any adverse reactions and quality problems should also be reported to the FDA’s MedWatch Program at 1-800-FDA-1088 or on the MedWatch website at www.fda.gov/medwatch.
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