Endoscopic Vessel Harvesting System Recalled Due to Polyimide Particulate Matter Risk
Maquet Cardiovascular is recalling the Vasoview Hemopro Endoscopic Vessel Harvesting System (model VH-3000-W) because polyimide particulate matter may be present on the device and could be introduced into arterial conduits during bypass graft surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a risk-of-harm scenario where polyimide particulate matter could be introduced into arterial conduits during critical cardiac bypass surgery. No illnesses or injuries have been reported in the source text, and the hazard is presently theoretical, placing this at the High severity level.
Plain-English summary
Maquet Cardiovascular, LLC is recalling the Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W, due to a risk of polyimide particulate matter being present on the endoscopic harvesting vessel system.
During coronary artery bypass graft (CABG) or peripheral bypass graft surgery, polyimide particulate matter present on the device could be introduced into the arterial conduit. This poses a potential safety risk to patients undergoing these procedures.
The recall affects 554 units that were distributed outside the United States, including China, Brazil, and Hong Kong. The affected lot numbers are 3000283735, 3000293031, 3000310304, and 3000333956 (UDI-DI: 00607567700413).
Healthcare facilities and surgeons using this device should discontinue use of affected units and contact Maquet Cardiovascular, LLC for guidance on product replacement or return.
The recalled product
- Product
- Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3000-W .
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- polyimide-particulate
- arterial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 00607567700413
- Lots: 3000283735
- 3000293031
- 3000310304
- 3000333956.
Distribution
Distribution scope not specified by the agency.
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