FDA recall, , Moderate risk
Vasoview Hemopro 2 Endoscopic Vessel Harvesting System
The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System was exposed to an out-of-specification sterilization dose.
Summary by Recall Canary from the FDA notice
What happened
Maquet Cardiovascular, LLC, of Wayne, New Jersey, recalled the Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000) after Getinge identified that devices from a specific lot were exposed to an out-of-specification sterilization dose during a gamma sterilization run performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026. The recall began June 2, 2026, and was added to FDA's Enforcement Report on July 15, 2026.
The recalled system is a sterile, single-use Class II device cleared for marketing under 510(k) number K101274. The recall involves 205 units distributed in California, Florida, Georgia, New York, Oregon, South Carolina and Texas.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Vasoview Hemopro 2 Endoscopic Vessel Harvesting System
- Model number
- VH-4000
- UDI-DI
- 00607567700406
- 3000547797
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of New York, California, South Carolina, Florida, Texas, Georgia, Oregon.
- Company
- Maquet Cardiovascular, LLCWayne, New Jersey
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99259
- Recall number
- Z-2741-2026
- Quantity recalled
- 205 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
