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The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System… recallZ-1622-2025 · Maquet Cardiovascular, LLC · initiated Mar 20, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected]. Questions can be directed to Maquet/Getinge Customer Support at 888-880-2874.

Recall details

Recall number
Z-1622-2025
Status
Open, Classified
Initiated by the company
Mar 20, 2025
Posted by the FDA
Apr 18, 2025
Recalling firm
Maquet Cardiovascular, LLC
Quantity
22,244 units
Product code
GEI
FDA submissions
K101274
Distribution
Worldwide distribution - US Nationwide and the countries of Mexico, United Arab Emirates, Singapore, India, Australia, Canada, Brazil, Hong Kong, Japan, South Korea, New Zealand.

Product description

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 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 (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K101274 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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