Vascular Patch Recalled for Flaw Linked to Blood Clots

June 5, 2015 — Baxter International Inc. has issued a voluntary recall for about 4,000 Vascu-Guard patches after receiving complaints from customers who had trouble distinguishing the rough or smooth side of the patch.

According to the FDA, there is an increased risk of vessel thrombosis (blood clots) and/or embolisms if the patch is accidentally placed with the rough side towards the bloodstream. The problem is due to a new packaging configuration.

The Vascu-Guard Patch is an implant that is used to repair peripheral blood vessels in many areas of the body. It is derived from bovine pericardium.

Unfortunately, there is a deviation in the surface texture of the patch in a new packaging configuration. According to the manufacturer, this could lead to blood clots and strokes:

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

No causal relationship has been established. There is an inherent risk of blood clots and embolisms in patients with underlying vascular diseases who are treated with this product, which could make it difficult to determine what caused the patient’s injury.

Product codes included in the recall:

• 1504026 – VASCU-GUARD TS 1x6cm
• 1504028 – VASCU-GUARD TS 0.8x8cm
• 1504030 – VASCU-GUARD TS 1x10cm
• 1504032 -VASCU-GUARD TS 2x9cm

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