Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes… — Class II medical device recall Z-2533-2016
Terminated recall by Baxter Healthcare Corp., reported 2016-08-24, distributed nationwide. Baxter is issuing a safety alert in response to postmarketing reports received for the VASC U-GUARD Peripheral
| Recall number | Z-2533-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2016-06-24 |
| Classified | 2016-08-12 |
| Reported by FDA | 2016-08-24 |
| Terminated | 2017-06-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CH, DE, ES, FI, GB, GR, IE, IT, KR, NL, NO, PL, SA, SE |
| Lot numbers | SP16A04-1108918, SP16A04-1108933, SP16A04-1108941, SP16A04-1108956, SP16A04-1108974, SP16A06-1110391, SP16A11-1111696, SP16A12-1111872, SP16A12-1111926, SP16A12-1111931, SP16A12-1111933, SP16A12-1111938, SP16A12-1111942, SP16A12-1111947, SP16A12-1111952, SP16A12-1112283, SP16A12-1112284, SP16A14-1112703, SP16A14-1112720, SP16A18-1113372, SP16A19-1114051, SP16A19-1114056, SP16A20-1114346, SP16A20-1114352, SP16A21-1114790, SP16A21-1114800, SP16A21-1114802, SP16A21-1114805, SP16A27-1116312, SP16A29-1116884, SP16B04-1118465, SP16B04-1118471, SP16B04-1118475, SP16B05-1119212, SP16B05-1119217, SP16B08-1119650, SP16B08-1119654, SP16B08-1119720, SP16B12-1121361, SP16B12-1121365 and 121 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2533-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.