Recall Z-2636-2025— Maquet Cardiovascular, LLC

Name: FDA recall Z-2636-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-06

Class II · Ongoing

Class II FDA medical device recall by Maquet Cardiovascular, LLC, initiated 2025-08-06. It names one FDA 510(k) clearance: K251238. 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..

Recalling firm: Maquet Cardiovascular, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-08-06
Firm location: Wayne, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K251238 — Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000) +2 moreMaquet Cardiovascular, LLC·cleared 2025-05-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.