TemporaryFDAOngoing
Can cause harm that is usually temporary.
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.
Check the device or its packaging for
UDI 00607567700406, Serial/Lot Number 3000547797
- Why
- 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.
- Distributed
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Company
- Maquet Cardiovascular, LLC
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2741-2026 · retrieved 15 July 2026
Read the official notice