Abbott recalls catheters

LIBERTYVILLE TOWNSHIP -- Abbott Laboratories said Thursday it has conducted a voluntary recall through the Food and Drug Administration of three lots of the Powersail coronary dilatation catheters from U.S. 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, it may cause a leak of contrast material during use, which could lead to catheter functional failures, an air embolism or myocardial infarction, which has the potential to lead to death.

Abbott said it has contacted all affected customers. The rest are in the company's possession or are in transit.

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.

One complaint reported that the patient had evidence of a post-procedural myocardial infarction and was now reported to be doing well, Abbott said.