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A recall has been issued for Baxter Healthcare, VASCU-GUARD Peripheral Vascular Patch because it may be difficult for surgeons to distinguish the smooth side from the rough side of the implant. 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 (thrombus) may form on the patch. This may 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. Patients who need repair of smaller arteries are at higher risk of blood clots forming within a blood vessel because of slower flow of blood through those vessels. Patients who have blood disorders where excessive blood clots form may also be at a higher risk of forming clots on the surface of the device. The firm reported 51 complaints related to this issue and one serious injury. For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm449825.htm
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