Class 1 Recall: Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage
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.
Tue Apr 19 2016
Class 1 Recall: Boston Scientific Corporation Recalls Fetch 2 Aspiration Catheter Due to Shaft Breakage
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injury or death.
Recalled Product:
- Fetch 2 Aspiration Catheter
- Model number: 109400-001
- Lot numbers: See list below
- 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
Device Use
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.
Reason for Recall
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.
Who May be Affected
- Patient groups undergoing a thrombectomy procedure using this device
- Health care professionals using this device to conduct thrombectomy procedures
What to Do
On April 8, 2016, Boston Scientific Corporation issued a news releasedisclaimer icon advising all affected customers to:
- Discontinue the use of all affected products immediately
- Return unused products to Boston Scientific Corporation
- Contact a Boston Scientific Corporation representative at 1-800-811-3211 for questions
Date Recall Initiated:
March 22, 2016