FDA Device recall Z-1882-2020
HEMASHIELD PLATINUM Woven Double Velour Vascular Graft-4 Branch, Product Code: M00202175930P0 - 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 Graft-4 Branch, Product Code: M00202175930P0 - 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-1882-2020 |
| 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 Graft-4 Branch, Product Code: M00202175930P0 - 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: 1131533749 1131512226 1137644576 1143574839 1143575130 1148758791 1148780115 1148765763 1148821303 11…Serial Numbers: 1131533749 1131512226 1137644576 1143574839 1143575130 1148758791 1148780115 1148765763 1148821303 1148781616 1148788961 1148782980 1162315753 1165124869 1192273190 1135377032 1136549649 1137644693 1148748780 1162373559 |
|---|
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-1882-2020%22
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