Baxter Recalls VASCU-GUARD Patches Due to Bleeding Reports
Baxter Healthcare is recalling VASCU-GUARD Peripheral Vascular Patches due to postmarketing reports of intraoperative and postoperative bleeding, including one fatal outcome.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that one report involved a case with a fatal outcome. Per the severity rubric, if reported deaths exist anywhere in the source text, the score is 5 (Critical) regardless of other factors.
Plain-English summary
Baxter Healthcare Corp. is issuing a safety alert and recall for the Synovis VASCU-GUARD Peripheral Vascular Patch. The recall involves specific sizes and product codes, including VG0106N, VG0108N, VG0110N, and VG0209N. The devices are prepared from bovine pericardium and were distributed nationwide in the United States, including Puerto Rico, as well as to several international markets.
The recall is in response to postmarketing reports of intraoperative or postoperative bleeding episodes that required additional clinical intervention. One of these reports involved a case with a fatal outcome. An update dated September 1, 2016, indicates that Baxter issued a notice retrieving 6 specific lots of the device due to the increased number of postmarketing reports related to bleeding.
Healthcare providers and patients should check their inventory and records for the affected product codes and lot numbers listed in the official recall notice. If the device has been used, clinicians should monitor patients for signs of bleeding complications. Consumers and medical facilities should contact Baxter Healthcare for further instructions on returning the affected devices.
The recalled product
- 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 bovi
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Medical Device — Surgical Patch
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code VG0106N
- Lot #: SP16A04-1108933
- SP16A11-1111696
- SP16A12-1111933
- SP16A12-1111938
- SP16A12-1111942
- SP16A12-1111947
- SP16A27-1116312
- SP16A29-1116884
- SP16B04-1118465
- SP16B08-1119650
- SP16B12-1121361
- SP16B22-1123979
- SP16B24-1124658
- SP16C01-1126439
- SP16C01-1126508
- SP16C07-1128790
- SP16C08-1129067
- SP16C09-1129905
- SP16C10-1130129
Distribution
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