Z-0723-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 24, 2024
- Initiation Date
- December 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 554 units (OUS)
Product Description
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
Reason for Recall
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.
Distribution Pattern
US: OUS: China, Brazil, Hong Kong.
Code Information
UDI-DI: 00607567700413, Lots: 3000283735, 3000293031, 3000310304, 3000333956.