Maquet Cardiovascular, LLC Recall 93615
Description: Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Maquet Cardiovascular, LLC Recall 93615 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0723-2024 |
| Event ID | 93615 |
| Event Description | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . |
| Product Type | Devices |
| Distribution | US: OUS: China, Brazil, Hong Kong. |
| Quantity | 554 units (OUS) |
| Recall Reason | Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery. |
| Device Classification | 20240124 |
| Device Code Info | UDI-DI: 00607567700413, Lots: 3000283735, 3000293031, 3000310304, 3000333956. |
| Center Classification Date | 20240112 |
| Recall Initiation Date | 20231201 |
| Recalling Firm | Maquet Cardiovascular, LLC |
| Initial Notification | Letter |
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