FDANews
FDAnews Device Daily Bulletin

Boston Scientific Recalls All Fetch 2 Aspiration Catheters

April 13, 2016

Boston Scientific is recalling all models of its Fetch 2 Aspiration thrombectomy catheter following reports of shaft breakage during procedures.

The recall — designated as Class 1 by the FDA — involves 21,155 devices, which were manufactured between June 11, 2014 and Feb. 19.

In a statement, the FDA says the breakages occurred during the procedures, and the broken section either was removed while partially attached to the catheter shaft or retrieved with a snare. There have been no reports of patient injuries or deaths.

Boston Scientific sent notification letters March 22, urging customers to discontinue use of the product and outlining steps to return affected devices. Boston Scientific acquired the catheter product line from Bayer Medical Care. All affected catheters are labeled and packaged as Bayer products. — Anisa Jibrell