Boston Scientific voluntarily recalled all models of its Fetch 2 aspiration catheter after receiving complaints of shaft breakage during procedures to remove small blood clots from the coronary arteries.
The FDA classified the action as a Class 1 recall, although Boston Scientific said it had not received reports of patient injury or death. The recall affects all 21,155 devices on the market.
Boston Scientific said patients who previously underwent a thrombectomy procedure with the catheter were not at risk of any adverse events. When the shaft broke during the procedure, it was removed or retrieved with a snare. Patients had no further complications, according to Boston Scientific.
The catheters were manufactured between June 11, 2014, and Feb. 19, 2016. They are packaged and labeled as a Bayer Medical Care product. Boston Scientific acquired the Fetch 2 catheter portfolio from Bayer in 2014.