Endoscopic Vessel Harvesting System Recalled for C-Ring Wire Straightening
Maquet Cardiovascular recalled 2,463 VASOVIEW HEMOPRO 2 surgical systems due to C-Ring wire straightening and component misalignment affecting tool positioning. No injuries have been reported.
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 device recall with no reported adverse events, injuries, or hospitalizations. The defect creates a risk of improper device function and positioning during a surgical procedure; however, the explicit statement that no adverse events have occurred means the hazard remains theoretical, meeting the 'High' threshold per the rubric.
Plain-English summary
Maquet Cardiovascular, LLC has recalled the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System, a surgical device used for harvesting blood vessels. The recall affects 2,463 units in the United States and 330 units distributed internationally.
The recall stems from a manufacturing defect in which the C-Ring wire was straightened due to insufficient bend radius, and the distance between the C-Ring and the Harvesting Tool became closer than normal than intended. This defect affects the proper positioning and function of the cutting and cauterization components during the vessel harvesting procedure. The issue was identified through 27 complaints received between March 22, 2024, and April 30, 2024, affecting models VH-3500 and VH-4000.
No adverse events or patient complications have been reported in direct association with this defect. Healthcare facilities and surgeons using affected devices should stop use and contact Maquet Cardiovascular, LLC for instructions on device replacement or repair. Affected lot numbers and device identifiers are listed in the FDA recall notice Z-2338-2024.
The recalled product
- Product
- The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Extended Length Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and harvesting tool for cutting and cauterizin
- Manufacturer
- Maquet Cardiovascular, LLC
- Hazard
- mechanical-defect
- component-misalignment
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 (2)
- UDI-DI: 00607567700406 (VH-4000)
- 00607567700451 (VH-4001) Lot Numbers
Distribution
Distributed nationwide across the United States.
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