The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001
Sold At: Maquet Cardiovascular, LLC(US Nationwide distribution in the states of FL, IL, MD & TX.)
Recall #: FDA-DEVICE-Z-2636-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model No. C-VH-6000; UDI: 00607567701274; Lot/Serial No. 3000486429, 3000487231, 3000487726, 3000488639.
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Summary
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.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Maquet Cardiovascular, LLC for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.