FDA Device recall Z-1875-2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement o…
- FDA Device
- Class II
- terminated
- Published 2020-05-13
On 2020-05-13 the FDA classified a Class II recall of HEMASHIELD PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - Product Usage: for use in the replacement o… 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-1875-2020 |
| 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 PLATINUM Woven Double Velour Vascular Graft01 Branch, Product Code: M00202175834P0 - 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: 1069033761 1069030839 1071600069 1071620833 1071615770 1071620950 1074557517 1074562931 1077531880 11…Serial Numbers: 1069033761 1069030839 1071600069 1071620833 1071615770 1071620950 1074557517 1074562931 1077531880 1109551893 1109625685 1113411073 1115932310 1160529586 1160492194 1160491552 1160727457 1160529957 1182769563 1182780936 1182789351 1182792017 1183481796 1069032514 1115876907 1115936362 1137588685 |
|---|
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-1875-2020%22
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