Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N, 1 cm x 10 cm, product code VG0110N, and 2 cm x 9 cm, product code VG0209N. VASC U-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. Sterilized using aseptic processing techniques. The pericardium is procured from cattle originating in the United States. VASC-Guard is chemically sterilized using ethanol and propylene oxide. UPDATE 9/1/2016 Retrieval of devices only includes Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG0106N, 0.8 cm x 8 cm, product code VG0108N.

Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral Vascular Patch. Baxter has received reports for intraoperative or postoperative bleeding episodes, which required additional clinical intervention. One report involved a case with a fatal outcome. UPDATE 9/1/2016 Baxter issued a notice retrieving 6 lots of VASCU-GUARD due to the increased postmarketing reports related to intraoperative and postoperative bleeding.

Baxter sent a Safety Alert to customers via USPS overnight delivery beginning 6/24/2016. The letter told of the reported adverse events, asked for product that product immediately be discontinued from use, to segregate/quarantine all affected lots, and to return the enclosed customer reply form. General questions regarding the Safety Alert should be directed to Baxter Product Surveillance at 1-800-437-5176, between 8:00 am - 5:00 pm Central Time Monday thru Friday. Clinical inquiries can be directed to Baxter's Medical information at 1-800-933-0303, Monday thru Friday 8:00 am - 5:00 pm central time. UPDATE 9/1/2016 Baxter issued an Urgent Product Recall letter beginning 9/1/2016. This letter explained the issue and identified affected product that was to be removed from the consignee and returned to Baxter. Customer is to contact Baxter Healthcare Center for Service to arrange for return and credit. This can be done at 888-229-0001 Monday thru Friday 7:00 am - 6:00 pm Central Time. General questions regarding the recall can be addressed to Baxter Product Surveillance at 800-437-5179 Monday thru Friday, 8:00 am - 5:00 pm Central Time.