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 | Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool |
| Product | VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting. |
| Quantity | 418,076 units (326,608 US, 91,468 OUS) |
| Distribution | Nationwide distribution. International distribution to Australia, Austria, Bahrain, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Guatemala, Hong Kong, India, Iran, Iraq, Ireland, Italy, Japan, Jordan, Kenya, Kuwait, Malaysia, Mexico, Netherlands, Netherlands, New Zealand, Oman, Panama, Puerto Rico, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, S… |
| Initiated | 2024-12-09 |
| Classified | 2025-01-03 |
| Recall number | Z-0711-2025 |
| 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-0711-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95908/
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