FDAHealthAugust 6, 2025
Maquet Cardiovascular, LLC — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-60
⚠️ Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws not fully closed out of box, and heater wire lifted/flexed away from jaws.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 6, 2025
US Nationwide distribution in the states of FL, IL, MD & TX.
What's affected?
- Product
- Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches. The HP3 Harvesting Tool features two curved, insulated jaws with heating elements that operate through heat and pressure rather than radiofrequency energy.
- Lot code
- /Serial
Additional details
Model No. C-VH-6000; UDI: 00607567701274; Lot/Serial No. 3000486429, 3000487231, 3000487726, 3000488639.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 98 units.
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