A number of Baxter Vascu-Guard patches have been recalled after the manufacturer received complaints that users could not tell which side of the patch to apply, resulting in misuse and a number of reported problems involving strokes and blood clots.
The Vascu-Guard Peripheral Vascular Patch recall was announced by the FDA and Baxter on June 1, impacting four product codes related to reports of strokes and postoperative thrombosis.
The patches are used in peripheral vascular reconstruction, including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels, as well as arteriovenous access revisions.
According to the recall notice, the company received complaints from customers that they had a problem distinguishing the smooth side of the patch from the rough side, leading to incorrect orientation of the patches and the rough side being aimed toward the blood stream. Baxter warned that this error can increase the risk of vessel thrombosis and embolism.
Baxter says that the problem is caused by a deviation in the surface texture of the vascular patch in a new packaging configuration used by the recalled product codes. The company says it is continuing to investigate the problem, but warns that there is an inherent risk of thrombosis associated with vascular procedures involving patients with underlying vascular problems.
The recall affects the VASCU-GUARD TS 1x6cm with product code 1504026; the VASCU-GUARD TS 0.8x8cm with product code 1504028; the VASCU-GUARD TS 1x10cm with product code 1504030; and the VASCU-GUARD TS 2x9cm with product code 1504032.
The company says it began notifying its U.S. customers on May 2. They have been directed to remove all affected products from their inventories.
Customers with recalled patches are asked to return them to Baxter for credit by contacting the Baxter Healthcare Center at 1-888-229-0001. Consumers with questions can call Baxter at 1-800-422-9837 or by sending an e-mail to firstname.lastname@example.org. Consumers who have experienced any health issues should contact their healthcare provider.