Z-1622-2025Class II

The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm...

Name: Z-1622-2025 The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm...
Creator: Maquet Cardiovascular, LLC
Published: 2025-03-20
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2025-03-20 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Cardiovascular, LLC began a recall of The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended length endoscope. The Harvesting Cannula... on 2025-03-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1622-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-20
Posted: 2025-04-18
Recalling firm: Maquet Cardiovascular LLC
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 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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 22,244 units
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 codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1622-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1622-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-30	2025-04-18

Product code GEI

K101274Class IIVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemMaquet Cardiovascular, LLC / cleared 2010-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)