Vascular Patch Recalled Due to Surface Texture Problem

Baxter is voluntarily recalling 4 product codes of its Vascu-Guard Peripheral Vascular Patch due to difficulty distinguishing surface textures.

This patch is used in peripheral vascular reconstruction and arteriovenous access revisions. When the rough side of the patch is incorrectly implanted toward the bloodstream, blood clots may form and increase the risk of vessel thrombosis and embolism.

According to Baxter, a change in packaging caused the smooth surface of the patch to be too rough, and customers subsequently complained of difficulty distinguishing the smooth side from the rough side. As a result, Baxter has recalled product codes 1504026, 1500428, 1504030, and 1504032, which were distributed to 770 US customers from March 16, 2015, to May 1, 2015.

The company reported 51 complaints related to this issue and 1 serious injury.

“To date, Baxter has received a limited number of adverse event reports, including postoperative thrombosis and stroke, in which the recalled product codes have been used,” the firm stated. “Baxter is continuing to investigate these reports.”

Baxter began notifying all US customers of this recall on May 2, 2015, and recalled patches should be returned to Baxter for credit.

In addition to contacting the company directly, health care professionals and patients can report adverse effects to the FDA’s MedWatch Adverse Event Reporting program.

The same product presented in a plastic jar filled with sterile water and 1% propylene oxide is unaffected by this recall.