Maquet Cardiovascular recalled 98 Vasoview Hemopro 3 EVH systems nationwide across FL, IL, MD and TX after 16 out-of-box failure complaints. No serious injuries were reported. The failures occurred during limited launch before clinical use.
On August 5, 2025, Getinge voluntarily initiated a Medical Device Removal for the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System in response to reports of out-of-box failures discovered during the limited launch phase. There were sixteen complaints on the same date pertaining to specific failure modes, including 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. These sixteen complaints corresponded to sixteen total device malfunctions affecting devices that had not progressed to the pre-test step or clinical use. Notably, no serious injuries were reported in association with these device failures, as the non-conforming devices were identified during device inspection prior to patient exposure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Maquet Cardiovascular, LLC or your healthcare provider for instructions. Notification method: Telephone
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Vasoview Hemopro 3 EVH System is a vessel harvesting kit used with a 7 mm endoscope to cut and cauterize vessel branches during EVH procedures.
Out-of-box failures include deformities and uncompleted jaw closure and heater wire misalignment, detected during inspection before patient exposure.
This recall is not part of a broader pattern.
No injuries reported; devices flagged before clinical use. Facilities must halt use and return or service devices.
Model No. C-VH-6000; UDI 00607567701274; Lot/Serial Nos listed above
Refund or replacement timelines not specified; follow manufacturer guidance
Maintain photos of defects, serial numbers, communications with hospital procurement and manufacturer
Model No. C-VH-6000. UDI: 00607567701274. Lot/Serial Nos: 3000486429, 3000487231, 3000487726, 3000488639. Distribution: US nationwide in FL, IL, MD, TX. Quantity: 98 units. Sold/Used: Medical facilities. Manufacturer: Maquet Cardiovascular.
Sixteen complaints reported on the same date, August 5, 2025. No serious injuries associated with these device failures. Issues identified during inspection prior to patient exposure.
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