Z-2636-2025Class II

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

Name: Z-2636-2025 Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic...
Creator: Maquet Cardiovascular, LLC
Published: 2025-08-06
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2025-08-06 / Open, Classified

FDA source

Maquet Cardiovascular, LLC began a recall of 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... on 2025-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2636-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-06
Posted: 2025-09-25
Recalling firm: Maquet Cardiovascular LLC
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
FDA root cause: Under Investigation by firm
Action: Getinge Field Representatives contacted impacted accounts by telephone on 8/6/25 to notify them of this recall action and provide instructions for quarantine and return of affected devices. Consignees were asked to stop all visual inspection and return all HemoPro 3 units. Returns can be coordinated by calling or emailing Michele Kanis for an RMA at [email protected] or (408)635-0647. Consignees are to utilize HemoPro 2 in place of HemoPro 3 units. Getinge Field Representatives delivered an updated URGENT MEDICAL DEVICE RECALL notice starting on 10/6/25 dated October 2025. The written notification is a supplement to the verbal notification made previously.
Quantity in commerce: 98 units
Distribution: US Nationwide distribution in the states of FL, IL, MD & TX.
Product codes and lots: Model No. C-VH-6000; UDI: 00607567701274; Lot/Serial No. 3000486429, 3000487231, 3000487726, 3000488639.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2636-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2636-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-25

Product code GEI

K251238Class IIVasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000); Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001); Vasoview Hemopro 3 Power Supply (VH-6010)Maquet Cardiovascular, LLC / cleared 2025-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)