The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm extended len
Summary
The FDA issued a Class II for The VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System is designed for use i by Maquet Cardiovascular, LLC. Reason: 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.
Details
Source
Device Recall
External ID
Z-1622-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
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.
Lot/Code Info: 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.
Quantity Affected: 22,244 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-20
Company
Wayne, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Cardiovascular, LLC has 41 FDA actions in our database, including 37 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Cardiovascular, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Cardiovascular, LLC have FDA actions?
Maquet Cardiovascular, LLC has 41 FDA actions in our database, including 37 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1622-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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