Boston Scientific is recalling all models of its Fetch 2 Aspiration Catheter, due to complaints of shaft breakage, according to a company press release.
Classified as an FDA Class I recall, it means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.
The thrombectomy catheter is used during procedures to remove small blood clots from coronary arteries.
There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter.
All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications.
As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific.
Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product.
This device was manufactured between June 11, 2014 and Feb. 19, 2016. There are currently 21,155 devices on the market subject to this recall.