FDA: Boston Scientific recalls Fetch 2 Aspiration Catheter

Editor's Note

The Food and Drug Administration (FDA) on April 11 announced the recall by Boston Scientific (Marlborough, Massachusetts) of all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used to remove small blood clots from coronary arteries.

The recall was initiated because of complaints of shaft breakage during procedures. The fragments could lead to obstruction of blood flow or additional intervention to remove a fragment surgically.

The device was manufactured between June 11, 2014, and February 19, 2016.

AUDIENCE: Risk Manager, Surgery, Cardiology ISSUE: Boston Scientific has initiated a global, voluntary recall of all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage.