April 12, 2016
Fetch 2 Aspiration Catheter by Boston Scientific: Recall - Shaft Breakage
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.
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.
BACKGROUND: 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. There are currently 21,155 devices on the market subject to this recall. Refer to the Recall Notice for Fetch 2 Catheter UPNs.
RECOMMENDATION: 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. Physicians and healthcare facilities can direct questions to their Boston Scientific representative or, call 1-800-811-3211.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall Notice, at http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm495470.htm