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Maquet Cardiovascular, LLC recalls The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use
Recalled July 22, 2026 · FDA recall Z-2741-2026 · Maquet Cardiovascular
Hazard
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026. · FDA Class II
Units
205 units
Sold at
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
Description
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026.
Product
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000; UDI 00607567700406) is a sterile, single-use Class II device that was cleared for marketing by FDA under 510(k) number K101274.
Manufacturer(s)
Maquet Cardiovascular, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →