Boston Scientific has initiated a global, voluntary recall of all models of its Fetch 2 aspiration catheter. A press release reports that the catheters were recalled on 22 March 2016 because of complaints of shaft breakage. The FDA classified the action as a Class 1 recall—which means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.
According to the press release, there have been no reports of patient injury or death and there is not thought to be a 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. While this has not been reported, the press release notes, the most severe potential outcome of this breakage is embolism of device fragments. Such a complication could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically.
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, all recalled inventory is packaged and labelled 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.
- Fetch 2 Catheter UPNs
- FETCH2 US
- 109400-001
- FETCH2 OUS
- 109400-002
- FETCH2 Canada
- 109400-003
- FETCH2 Japan
- 109400-004
- FETCH2 EU
- 109400-005
Physicians and healthcare facilities can direct questions to their Boston Scientific representative or, call 1-800-811-3211. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online: www.fda.gov/medwatch/report.htm
