Boston Scientific Recalls Catheters

Boston Scientific Corp. is voluntarily recalling its iCross Coronary Imaging Catheters used in intravascular ultrasound imaging in candidates for transluminal coronary interventional procedures. Between April 1, 2010 and May 10 of this year, the company confirmed eight occurrences of catheter tip detachments in the United States and Puerto Rico due to embrittlement of the catheter material. The failures translate to a rate of 0.027 percent based on available market data.

According to Boston Scientific, the recall does not affect patients who already have received treatment with the devices because the potential problems occur during the procedure. A solution has been submitted to the U.S. Food and Drug Administration (FDA) for approval.

Potential health risks include vessel wall injury, thrombotic events, retained foreign body, foreign body embolization, myocardial infarction and death. There are additional risks related to percutaneous and surgical retrieval attempts, but the majority of retrievals to date have been successful (most often percutaneous).

The recall includes approximately 29,664 units distributed in the United States, Puerto Rico, Trinidad, Tobago and the American Virgin Islands. Boston Scientific will replace all returned iCross Coronary Imaging Catheters as well as Atlantis SR Pro Coronary Imaging Catheters without charge. The FDA has classified the recall as a Class I event.