The FDA announced on March 20, 2025, that Maquet Cardiovascular, LLC is recalling The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System due to a broken ceramic C-Ring hazard. Owners should contact the company for a remedy.
How to tell if you have it
- Brand: Maquet
- Product: The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System
- Model No.: VH-4000 (Hemopro 2), VH-4001 (Hemopro 2 w/ Vasoshield)
- UDI-DI: 00607567700406 (Hemopro 2), 00607567700451 (Hemopro 2 w/ Vasoshield)
- Lot/Serial No.: 3000436447, 3000437191, 3000439557, 3000439600, 3000439623, 3000439922, 3000440187, 3000440220, 3000440283, 3000440754, 3000440957, 3000440981, 3000440982, 3000441144, 3000441319, 3000441541, 3000441774, 3000442133, 3000442263, 3000442323, 3000442627, 3000442871, 3000442953, 3000442955, 3000443198, 3000443216, 3000443545, 3000443632, 3000443851, 3000444131, 3000444151, 3000444484, 3000445702, 3000445704, 3000445941, 3000446003, 3000446365, 3000446489, 3000446709, 3000446774, 3000447195, 3000447535, 3000447597, 3000447845, 3000448208, 3000448471, 3000448761, 3000449047, 3000449170, 3000449267, 3000450191, 3000450967
- Units affected: 22,244
The hazard
According to the FDA, there have been at least 12 complaints from users as of March 3, 2025, reporting that they identified the ceramic C-Ring to be broken in half during use of the device. The ceramic C-Ring has a potential to break while in use.
Context
GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since 2019-01-24. Other recent recalls of similar products include Maquet Vasoview Hemopro 2: Gamma Sterilization Issue (2026-06-02), Maquet Heartstring III Proximal Seal System Recall (2025-08-15), and Maquet Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Recall (2025-08-06). Other recent recalls of similar products include Olymp: Resection Sheath Model A22014A/T Recall (2025-11-11), Olympus Resection Sheath A2666T (2025-11-11), and Olympus A2642 Inner Sheath Recall (2025-11-11).