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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Vasoview Hemopro 2 Harvesting Systems Recalled for Broken Ceramic C-Rings

Agency Publication Date: April 18, 2025
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Summary

Maquet Cardiovascular is recalling approximately 22,244 Vasoview Hemopro 2 Endoscopic Vessel Harvesting Systems, including models VH-4000 and VH-4001. The recall was issued because a component called the ceramic C-Ring can break in half while the device is being used during surgery. There have been at least 12 reports of the ring breaking as of March 2025. The affected devices were manufactured between November 5, 2024, and February 14, 2025.

Risk

If the ceramic C-Ring breaks during a surgical procedure, it can lead to surgical delays or direct injury to the patient. Twelve users have already reported identifying broken rings while the device was in use.

What You Should Do

  1. This recall affects the Vasoview Hemopro 2 Endoscopic Vessel Harvesting System, models VH-4000 and VH-4001, manufactured with a ceramic C-Ring.
  2. Check your medical facility's inventory for these devices by identifying the model number and the lot or serial number on the product packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately.
  4. Contact Maquet Cardiovascular (Getinge) or your medical device distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA at 1-888-463-6332 for more information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Vasoview Hemopro 2 Endoscopic Vessel Harvesting System
Variants: Hemopro 2, Hemopro 2 w/ Vasoshield
Model / REF:
VH-4000
VH-4001
Serial Numbers (52):
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
UDI:
00607567700406
00607567700451
Date Ranges: Manufactured between November 5, 2024, and February 14, 2025

Quantity affected: 22,244 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96439
Status: Active
Manufacturer: Maquet Cardiovascular, LLC
Sold By: Hospitals and medical facilities; Direct medical device distribution
Manufactured In: United States
Units Affected: 22,244 units
Distributed To: Nationwide
Agency Last Updated: May 17, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.