Boston Scientific Corporation (BSC) Is Recalling Fetch 2 Aspiration Catheter Due to Shaft Breakage
The Fetch 2 Aspiration Catheter is intended to remove small blood clots from peripheral veins and coronary arteries (thrombectomy) to restore blood flow to the heart.
Boston Scientific Corporation is recalling the Fetch 2 Aspiration Catheter because the catheter shaft may break at various points along the device, before or during procedures. If breakage occurs while the device is in a patient, pieces of the catheter may block blood supply to the heart or blood vessels. This could result in the need for additional medical procedures, patient injury, or death.
- Fetch 2 Aspiration Catheter
- Model number: 109400-001
- Lot numbers: See list here at FDA
- Manufacturing dates: June 11, 2014 to February 19, 2016
- Distribution dates: June 24, 2014 to March 11, 2016
- Devices recalled in the U.S.: 17,455 nationwide, including D.C. and the Virgin Islands
Fetch 2 Catheter UPNs
There are currently 21,155 devices on the market subject to this recall.
- FETCH2 US
- FETCH2 OUS
- FETCH2 Canada
- FETCH2 Japan
- FETCH2 EU
According to BSC, 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 February 19, 2016.
Learn about Deep Vein Thrombosis (DVT)
Last Updated: 2016-04-19