Maquet Cardiovascular, LLC recalls The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System
- Recalling company
- Maquet Cardiovascular, LLC
- 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.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jun 2, 2026
- Reported
- Jul 22, 2026
- Distribution
- US Nationwide distribution in the states of NY, CA, SC, FL, TX, GA, OR.
- Status
- Ongoing
- Quantity
- 205 units
- Lot / codes
- UDI 00607567700406, Serial/Lot Number 3000547797
- Company location
- Wayne, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2741-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2741-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.