July 6, 2017
Update Regarding Investigation of Reported Adverse Events:
Following Baxter International, Inc.’s voluntary recall issued on June 24, 2016, the FDA has worked with the manufacturer to evaluate the severe bleeding and hematoma events reported following carotid endarterectomy (CEA) surgery. At this time, the FDA has not identified a root cause of the aforementioned bleeding events, and we have not been notified of any new events related to this issue since issuing the September 1, 2016 letter to health care providers.
Baxter’s voluntary recall closed on June 23, 2017. The FDA continues to recommend that health care providers discuss with their patients all available treatment options for CEA surgery, including their benefits and risks, before deciding the best treatment approach. Health care providers should also continue to report all adverse events related to the Vascu-Guard Peripheral Vascular Patch through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
- September 1, 2017: Potential Risk of Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers