Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes… — Class I medical device recall Z-1637-2015
Terminated recall by Synovis Surgical Innovations, Inc., reported 2015-06-10, distributed nationwide. Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complain
| Recall number | Z-1637-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synovis Surgical Innovations, Inc., Saint Paul, MN, United States |
| Recall initiated | 2015-05-02 |
| Classified | 2015-05-29 |
| Reported by FDA | 2015-06-10 |
| Terminated | 2016-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 3,974 |
Product
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product code 1504028, 1x10cm, product code 1504030, and 2x9cm, product code 1504032. VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile. VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Reason for recall
Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch due to complaints received for difficulty in distinguishing the smooth from rough surface.
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-1637-2015. 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.