Abbott Catheter Recall: Powersail Coronary Dilation Catheters

The FDA has classified a recall issued by Abbott for their Powersail Coronary Dilation Catheters as a “class 1” recall, meaning that continued use of the catheters could potentially lead to serioud injury or death.

The Abbott catheter recall applies to four specific lots, three of which were distributed in the United States and one that was shipped overseas. The Powersail Coronary Dilation Catheters could be defective and lead to a heart attack, air embolism or other life-threatening injury.

At least four complaints were received by Abbott, involving one from each lot, where the distal shaft of a catheter appeared to be damaged. The damage could allow contrast material to leak, potentially causing the catheter to fail. One patient appears to have suffered a myocardial infarction as a result of the defect, but they have reportedly recovered.

The affected lots include:

• POWERSAIL 3.25x18mm, Product Number 1005524-18, Lot Number 7101051, Expiration Date 09-2009
• POWERSAIL 4.0x8mm, Product Number 1005726-08, Lot Number 7112051, Expiration Date 10-2009
• POWERSAIL 2.75x18mm, Product Number 1005522-18, Lot Number 8012151, Expiration Date 12-2009
• POWERSAIL 3.25x8mm, Product Number 1005524-08, Lot Number 8053061, Expiration Date 04-2010

Signs of a myocardial infarction, or heart attack, can include sudden chest pain that typically radiates to the left arm or left side of the neck, shortness of breath, nausea, vomiting, palpitations, sweating and anxiety.

An air embolism can result in loss of consciousness, stroke, convulsions, heart attack, chest pains, shortness of breath, low blood pressure, irregular heart beat, blurred vision, disorientation, or a faint blue tone to the skin.

Customers are advised to stop using any units from the recalled lots. Unsold units have been recovered by the company or are in transit. Any adverse reactions should report the incident to FDA’s MedWatch Program at 1-800-FDA-1088, or on the MedWatch website at www.fda.gov/medwatch.