Class II — Maquet Cardiovascular, LLC
| Recalling firm | Maquet Cardiovascular LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W . |
| Quantity | 554 units (OUS) |
| Distribution | US: OUS: China, Brazil, Hong Kong. |
| Initiated | 2023-12-01 |
| Classified | 2024-01-12 |
| Recall number | Z-0723-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Cardiovascular, LLC (Z-0723-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93615/
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