Baxter Recalls Vascu-Guard Peripheral Vascular PatchJun 5, 2015
According to a safety alert posted on the U.S. Food and Drug Administration's (FDA) website on June 3, 2015, Baxter International, Inc. is recalling some of its Vascu-Guard Peripheral Vascular Patches. The voluntary recall is being issued because customers complained that it is difficult to differentiate between the smooth and rough surfaces. "This is due to a deviation in the surface texture of the vascular patch in a new packaging configuration. Incorrect orientation of the patch with the rough side toward the bloodstream may increase the risk of vessel thrombosis and/or embolism." the safety alert reads.
The recall affects the following four product codes: 1a504026 VASCU-GUARD TS 1x6cm, 1504028 VASCU-GUARD TS 0.8x8cm, 1504030 VASCU-GUARD TS 1x10cm and 1504032 VASCU-GUARD TS 2x9cm.
The device is used in the reconstruction of peripheral vessels, including carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Baxter has received a "limited number" of adverse events associated with this issue, including postoperative thrombosis and stroke. The company's press release notes that the patient population has an inherent risk of blood clots when undergoing vascular procedures.
Customers are advised to remove the recalled product from their facilities and return them to Baxter. The company began notifying customers of the recall on May 2nd.