FDA Device recall Z-2636-2025

Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000

• FDA Device
• Class II
• ongoing
• Published 2025-10-01

On 2025-10-01 the FDA classified a Class II recall of Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000 by Maquet Cardiovascular, citing 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 dista….

Read the official FDA Device notice

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.

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2636-2025%22

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