Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Abbott catheter recall: Abbott is recalling four lots of Powersail coronary dilation catheters--three from U.S. distribution and one from international distribution--following four complaints of damage to the distal shaft of the catheter, firm announced July 28. FDA is classifying the recall as Class I, the most serious category, according to the firm. The observed damage could cause the contrast material to leak, potentially causing clinical problems such as air embolism or myocardial infarction, Abbott says. Sales reps have instructed all customers to stop using the affected lots. Patients already successfully treated with Powersail coronary catheters are not affected by the recall