Baxter is recalling the VASCU-GUARD patch because it may be difficult for surgeons to distinguish the smooth side from the rough side of the implant, according to the FDA.
A change in packaging caused the smooth surface of the patch to be too rough. If the rough side of the patch is implanted in the incorrect way, blood clots may form on the patch.
This can expose patients to significant health risks, including the movement of blood clots into the blood stream (embolism), reduced blood flow, stroke, organ failure, or death.
The firm reported 51 complaints related to this issue and one serious injury.
