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U.S. Department of Health and Human Services

Class 2 Device Recall Vasoview Hemopro 2 Endoscopic Vessel Harvesting Systems (VH4000 and VH4001)

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 Class 2 Device Recall Vasoview Hemopro 2 Endoscopic Vessel Harvesting Systems (VH4000 and VH4001)see related information
Date Initiated by FirmMarch 20, 2025
Date PostedApril 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1622-2025
Recall Event ID 96439
510(K)NumberK101274 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductThe 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 for spot cautery. The activation toggle is used to control the jaws to activate the heating elements. Positioning the device, cutting, and cauterization are performed under endoscopic visualization. The device is intended for specific use with the VASOVIEW HEMOPRO Power Supply, VASOVIEW HEMOPRO 2 extension cable, and an adapter cable.
Code Information 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.
Recalling Firm/
Manufacturer		 Maquet Cardiovascular, LLC
45 Barbour Pond Dr
Wayne NJ 07470-2094
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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.
Quantity in Commerce22,244 units
DistributionWorldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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