Boston Scientific iCross IVUS Catheter Recalled

Disclosures

May 31, 2011

May 30, 2011 (Natick, Massachusetts) — Boston Scientific has announced a "voluntary recall" of its iCross intravascular ultrasound (IVUS) imaging catheter [1].

The class I recall--which applies to 29 664 units distributed to hospitals in the US, Puerto Rico, Trinidad and Tobago, and the US Virgin Islands--was taken after eight instances of catheter-tip detachment "due to embrittlement of the catheter material," the company said in a press release.

In the "majority" of the eight cases, all of which occurred in the past two months, the detached tip was successfully retrieved, according to the company, which does not refer to any clinical consequences the patients may have experienced as a result of the detachment or retrieval procedure. It does, however, list a number of "potential health risks associated with this type of failure," such as embolization of the detached material, thrombotic events, MI, and death.

The recall "does not affect patients who have already received treatment with the recalled devices because the potential problem occurs during the procedure."

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