August 3, 2009 – Abbott is conducting a voluntary recall of its POWERSAIL Coronary Dilatation Catheters, which may be damaged and can cause a leak of contrast material during use, possibly leading to catheter functional failures, including air embolism and myocardial infarction.
The company is recalling three lots 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, the company wanted to withdraw the damaged items to avoid patient safety issues.
Abbott Vascular's sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the part numbers and lot numbers listed below. 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 FDA has been apprised of this action, and it has classified this action as a class I recall.
The affected devices can be identified by the part number and lot number combinations shown below:
• POWERSAIL 3.25x18mm (U.S.), 1005524-18, 7101051
• POWERSAIL 4.0x8mm (CE), 1005726-08, 7112051
• POWERSAIL 2.75x18mm (U.S.), 1005522, 8012151
• POWERSAIL 3.25x8mm (U.S.), 1005524-08, 8053061
Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at (800) 227-9902.
For more information: www.fda.gov/medwatch