Getinge recalled 98 units of the VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting System on August 5, 2025. The recall addresses out-of-box failures including malfunctioning jaws and heater wires. No serious injuries were reported related to these failures.
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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The recalled models include VH-6000, VH-6001, and VH-6010. These devices were distributed nationwide in the U.S., specifically in Florida, Illinois, Maryland, and Texas. The quantity recalled is 98 units.
Reports indicate out-of-box failures, including angled deformities at the jaw attachment site and non-closure of the jaws. Sixteen complaints detailed malfunction issues before the devices reached clinical use.
No serious injuries occurred. Sixteen complaints were reported regarding the malfunction of the devices.
Stop using the VASOVIEW HEMOPRO 3 immediately. Contact Maquet Cardiovascular, LLC for further instructions on the recall.
For more information, call Maquet Cardiovascular, LLC. Visit the recall notice at the FDA website for detailed instructions.
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