FDAFDA · Food and drugs·Recall number Z-0723-2024
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Published January 24, 2024 · Recall initiated: December 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Maquet Cardiovascular, LLC
- Distributor
- US: OUS: China, Brazil, Hong Kong.
- Lot
- UDI-DI: 00607567700413, Lots: 3000283735, 3000293031, 3000310304, 3000333956.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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