Abbott Issues Recall of POWERSAIL Coronary Dilatation Catheters

Abbott has conducted a voluntary recall of 3 lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of 4 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 of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

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 U.S. and international health care organizations.

JULY-31-09: Abbott Issues Recall of POWERSAIL Coronary Dilatation Catheters [FDA: ABBOTT RECALLS POWERSAIL CORONARY DILATATION CATHETERS]

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Published on Jul-31-09