Class I — 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 I |
| Status | Ongoing |
| Reason | There were reports of the silicone detaching from the Jaws of the Harvesting Tool during use. |
| Product | VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500 |
| Quantity | 28,809 units |
| Distribution | Worldwide distribution. US Nationwide. Brazil, China, and Hong Kong. |
| Initiated | 2024-09-20 |
| Classified | 2024-10-25 |
| Recall number | Z-0092-2025 |
| 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 I recall — Maquet Cardiovascular, LLC (Z-0092-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95434/
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