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# No New Bleeding Reports With Baxter Vascular Patch: FDA
- URL: https://www.fdaweb.com/no-new-bleeding-reports-with-baxter-vascular-patch-fda/
- Published: 2017-07-10T12:00:00.000Z
- Updated: 2026-09-14T22:33:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139079

FDA says that it has not received any additional adverse events associated with severe bleeding and hematomas with axter International’s Vascu-Guard peripheral vascular patch during carotid endarterectomy (CEA) since the agency sent a 9/2016 [letter to health care providers](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm518804.htm?ref=fdaweb.com). Baxter conducted a [recall](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148062&ref=fdaweb.com) of the device 6/2016 and the recall has since closed, an updated [agency notice](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm565860.htm?ref=fdaweb.com) says. It notes that it has not identified a root cause for the bleeding events, and it 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.