FDA Device recall Z-0996-2023
Vasoshield Syringe Packs, Model VH-5001
- FDA Device
- Class II
- ongoing
- Published 2023-01-25
On 2023-01-25 the FDA classified a Class II recall of Vasoshield Syringe Packs, Model VH-5001 by Maquet Cardiovascular, citing ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic ev….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0996-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-22 |
| Published | 2023-01-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Vasoshield Syringe Packs, Model VH-5001
Reason
Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.
Identifiers
| code_info | UDI-DI: 00607567700468; Serial Numbers: 25147126, 25151632, 25152389, 25152964, 25163138, 25162077 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Maquet Cardiovascular
- The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000
FDA Device · Class II · 2026-07-22 · Maquet Cardiovascular - Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000
FDA Device · Class II · 2025-10-01 · Maquet Cardiovascular - Heartstring III Proximal Seal System
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular
All Maquet Cardiovascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0996-2023%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.