FDA Device recall Z-1859-2020
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the…
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the… by Maquet Cardiovascular, citing potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1859-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-07 |
| Published | 2020-05-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955010 - Product Usage: For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
Reason
Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
Identifiers
| code_info | Serial Numbers: 1175589583 1175603872 1175612382 1179652954 1179653616 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1859-2020%22
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