Abbott Vascular’s sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the lot numbers 7101051, 7112051, 8012151, 8053061. 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.
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. Subsequently, the patient was reported to be doing well.
The United States Food and Drug Administration (FDA) has been apprised of this action, and it has classified this action as a Class I recall.
The POWERSAIL Coronary Dilatation Catheter is distributed for prescription use only to approved US and international health care organizations. Affected devices can be identified by the part number and lot number.
