Abbott Issues Voluntary Recall of POWERSAIL Coronary Dilatation Catheters
MedSun: Newsletter #39, August 2009
Recall - Firm Press Release
Abbott has conducted a voluntary recall of three lots of POWERSAIL Coronary Dilatation Catheters from United States 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 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.
Recall – Firm Press Release. Abbott Issues Voluntary Recall of POWERSAIL® Coronary Dilatation Catheters. July 30, 2009.