June 5, 2015 — The Baxter Vascu-Guard patch has been recalled after customers reported having trouble distinguishing the rough from smooth side, which could increase a patient’s risk of blood clots, embolism, and stroke.
The manufacturer, Baxter International, has received reports of adverse events, including post-operative thrombosis and stroke. However, because patients who receive the patch are already at risk of these adverse events, it is not clear that the patch caused these injuries.
The Vascu-Guard Patch is made of bovine peritoneum. It is implanted in patients during reconstructive surgery on major blood vessels in many parts of the body.
According to the FDA:
“[The problem] 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.”
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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