Recall Z-2636-2025
Maquet Cardiovascular, LLC · initiated August 6, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model No. C-VH-6000; UDI: 00607567701274; Lot/Serial No. 3000486429, 3000487231, 3000487726, 3000488639.
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-determined cause: Under Investigation by firm
Action taken
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 michele.kanis@getinge.com 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.
Details
- Recall number
- Z-2636-2025
- Initiated
- August 6, 2025
- Posted by FDA
- September 25, 2025
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Quantity
- 98 units
- Distribution
- US Nationwide distribution in the states of FL, IL, MD & TX.
- Recalling firm
- Maquet Cardiovascular, LLC, Wayne, NJ