Hemashield Gold Knitted Microvel Double Velour Vascular Graft… — Class II medical device recall Z-1861-2020
Terminated recall by Maquet Cardiovascular, LLC, reported 2020-05-13, distributed nationwide. Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam li
| Recall number | Z-1861-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2020-04-07 |
| Classified | 2020-05-04 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2021-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, BE, BR, CA, CN, DE, ES, FI, FR, GB, IT, JP, KR, NL, PL, RS, SE |
| Serial numbers | 1176624815, 1176626841, 1176630871, 1176637748 |
Product
Hemashield Gold Knitted Microvel Double Velour Vascular Graft Axillo-bifemoral, Product Code: M002020955890 - Product Usage: for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Reason for recall
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
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-1861-2020. 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.