Device product
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Z-0723-2024
Product summary
- Event
- Event 93615
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 554 units (OUS)
- Official record key
device-enforcement:Z-0723-2024
Official wording
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.
Code information: UDI-DI: 00607567700413, Lots: 3000283735, 3000293031, 3000310304, 3000333956.
Distribution pattern: US: OUS: China, Brazil, Hong Kong.
Derived failure modes
-
Foreign material or chemical contamination
particulate matter