Vasoview Hemopro 3 Endoscopic Vessel Harvesting System… recallZ-2636-2025 · Maquet Cardiovascular, LLC · initiated Aug 6, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2636-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 6, 2025
- Posted by the FDA
- Sep 25, 2025
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- 98 units
- Product code
- GEI
- FDA submissions
- K251238
- Distribution
- US Nationwide distribution in the states of FL, IL, MD & TX.
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.
Code information (models, lots, serial numbers)
Model No. C-VH-6000; UDI: 00607567701274; Lot/Serial No. 3000486429, 3000487231, 3000487726, 3000488639.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vasoview Hemopro 3 Endoscopic Vessel Harvesting System VH-6000Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories1 recall12 reports
Other devices under the same FDA submission
1 device cleared under K251238 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- VASOVIEW HEMOPRO 3 VH-6010Maquet Cardiovascular LLC · Electrosurgical, Cutting & Coagulation & Accessories2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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