The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System recall (Maquet Cardiovascular, LLC)
Medical deviceClass IIOngoing
Summary: Maquet Cardiovascular, LLC is recalling 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.. Reason: 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.
What is being recalled
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.
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR. (states named: California, Florida, Georgia, New York, Oregon, South Carolina, Texas)
How to tell if yours is affected
UDI 00607567700406, Serial/Lot Number 3000547797
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2741-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | June 2, 2026 |
| Reported | July 22, 2026 |
| Company | Maquet Cardiovascular, LLC |
| Company location | Wayne, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 205 units |
More recalls from Maquet Cardiovascular, LLC · all medical device recalls · recalls from June 2026