Abbott Vascular has issued a voluntary recall of four lots of its Powersail coronary dilation catheter after the company received reports of problems related to its distal shaft. The total number of catheters recalled is estimated to be 550. One complaint showed evidence that a patient suffered a post-procedure heart attack. The FDA classified the voluntary recall as Class I, indicating that the defective product could seriously injure or kill patients. While the product defect can be detected prior to use, there are serious consequences if the defect is not found prior to use, including myocardial infarction and embolism. The defective distal shaft may leak contrast fluid which in turn may cause catheter functional failures and serious injury, including death. An Abbott spokesperson has stated that all defective catheters have been accounted for and the ones that were used performed successfully.
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