The FDA announced on 2023-12-01 that Maquet Cardiovascular, LLC is recalling the Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W. The recall addresses the risk of polyimide particulate matter being introduced into patients during surgery.
How to tell if you have it
- Brand: Maquet Cardiovascular
- Product: Vasoview Hemopro Endoscopic Vessel Harvesting System
- Model: VH-3000-W
- UDI-DI: 00607567700413
- Lots: 3000283735, 3000293031, 3000310304, 3000333956
The hazard
The risk involves 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.
Context
GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since 2019-01-24. Recent brand recalls include a gamma sterilization issue for the Vasoview Hemopro 2 on 2026-06-02 and out-of-box failures for the Vasoview Hemopro 3 on 2025-08-06.