VASOVIEW HEMOPRO 2 (Maquet) – ceramic C-Ring breakage (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula has four lumens which house the endoscope, C-Ring, distal lens washer tube, and Harvesting Tool for cutting and cauterizing vessel branches. The Harvesting Tool has two curved jaws. One of the jaws contains the heating elements for branch cutting and cauterization and spot cautery. An area near the tip of the convex side of the jaw is used
Brand
Maquet Cardiovascular, LLC
Lot Codes / Batch Numbers
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.
Products Sold
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.
Maquet Cardiovascular, LLC is recalling The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with t due to 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 u. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by 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. Maquet/Getinge determined that the issue was limited to the units of VH-4000 and VH-4001 manufactured with ceramic C-Ring, and the ceramic C-Ring was implemented in the Hemopro 2 devices from November 5, 2024, through February 14, 2025.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE NOTIFICATION dated March 2025 was mailed to consignees. The notification provides instructions to users on how to proceed with a procedure if a ceramic C-Ring break occurs. If a consignee has a C-Ring break they are asked to save the device and complete the provided return form so Maquet Cardiovascular can conduct an investigation. Maquet instructs consignees to forward the notification to device users and to facilities to which product was further distributed for their awareness. Consignees are asked to return the provided response form by email to recallresponses.qrc@getinge.com. Questions can be directed to Maquet/Getinge Customer Support at 888-880-2874.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026