Baxter Recalls Peripheral Vascular Patch
Baxter International on Monday announced a recall of four product codes of its Vascu-Guard peripheral vascular patch after receiving complaints that distinguishing the smooth from rough surface of the device proved difficult. The FDA has labeled the recall a Class I.
The complaints stem from changes in the devices’ packaging configurations, the company says. If the rough surface orients toward the bloodstream, it could lead to vessel thrombosis and/or embolism.
The devicemaker claims it has received few adverse event reports involving the products, among them postoperative thrombosis and stroke, and is investigating the reports. Risk of thrombosis is correlated with vascular procedures and the devices have not been demonstrated to be the cause of the events.
Baxter started notifying U.S. customers May 2 of the issue, requesting they locate all affected products and return them to the company. The devicemaker is urging consumers to call or email with questions and concerns, as well as to contact medical professionals if they experience any problems related to the devices.
The Vascu-Guard was developed for peripheral vascular reconstruction, including the carotid, renal, iliac, femoral, profunda and tibial blood vessels and arteriovenous access revisions. The patch is available in a plastic jar filled with sterile water and 1 percent propylene oxide — these products are unaffected by the recall. — Jason Scott