FDA Device recall Z-1860-2020
Hemashield Gold Knitted Microvel Double Velour Vascular Graft-Axillo-bifemoral, Product Code: M002020955880 - 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: M002020955880 - 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-1860-2020 |
| 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: M002020955880 - 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: 1175590223 1175624927 1179649703 1183011925 1183008537 1183011066 1191609117 1191599092 1183020201 1183073432 1183039720 |
|---|
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-1860-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.