Packaging Change Leads to Recall for Baxter International Vascu-Guard Patch

Baxter International, Inc. has issued a voluntary recall for four lots of a peripheral vascular patch because a change in packaging affected the patches’ surface, making it difficult to correctly orient the patch, possibly endangering patients.

The Illinois company reported 51 complaints involving the patch to the Food and Drug Administration (FDA), including postoperative thrombosis and stroke, according to an FDA statement. “Baxter is in the process of an in-depth investigation, and will share additional information as it becomes available,” a Baxter spokesman John O’Malley said via email to Qmed.The Vascu-Guard patch is used to rebuild peripheral blood vessels such as the carotid in the neck and the renal in the kidneys, Qmed explains. Baxter is recalling the patch because it may be difficult for surgeons to distinguish the smooth side from the rough side of the implant, according to FDA. The packaging change caused the smooth surface of the patch to be too rough. If the surgeon implants the rough side of the patch incorrectly (toward the bloodstream), blood clots may form on the patch, exposing the patient to embolism, reduced blood flow, stroke, organ failure, or death, the FDA said.

Patients who need repair of smaller arteries are at higher risk of blood clots forming within a blood vessel because blood flows more slowly through those vessels, the FDA said. Patients whose blood disorders cause excessive clots to form may also be at a higher risk of forming clots on the surface of the patch. In a statement, Baxter said, “no causal association has been established” between the recalled patches and adverse health events. The product codes for the recalled patches are available on the FDA’s website. The company is continuing to investigate the issue, Qmed reports.

The FDA categorizes this as a Class I recall, the most serious recall category, reserved for situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

Baxter began notifying customers of the recall on May 2, 2015. The company advises health care facilities to remove the recalled patches from inventory and return them to Baxter for credit. Customers should contact Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, from 7:00 a.m. and 6:00 p.m., Central Time, for further information. The company says the Vascu-Guard patches packed in a plastic jar filled with sterile water and 1% propylene oxide are unaffected by this recall and can still be purchased.

The FDA encourages healthcare professionals and patients to report any adverse events or side effects related to the use of the Vascu-Guard patch to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/MedWatch/report.

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