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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

Maquet Cardiovascular, LLC: VasoView HemoPro Systems Recalled for Unintended Cautery and Electrical Failure

Agency Publication Date: June 24, 2024
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Summary

Maquet Cardiovascular is recalling approximately 467,223 VasoView HemoPro and HemoPro 2 Endoscopic Vessel Harvesting Systems because fluid can leak into the tool handle. This defect can cause the surgical tool to either fail to provide heat for cauterization or, more dangerously, activate the heating elements when not intended. These systems are used by surgeons to harvest blood vessels for bypass surgeries. Consumers and healthcare providers should contact the manufacturer regarding this issue.

Risk

Fluid entering the device handle can cause a short circuit, potentially leading to surgical delays if the tool fails or causing unintended burns and tissue damage if the tool activates without the surgeon's command.

What You Should Do

  1. Identify if you have the affected VasoView HemoPro 2 models VH-4000 (UDI-DI: 00607567700406) or VH-4001 (UDI-DI: 00607567700451). For these models, all lot numbers currently within their expiration dates are affected.
  2. Check for affected VasoView HemoPro models VH-3500 (UDI: 00607567701250) or VH-3000-W (UDI: 00607567700345) specifically by searching for 112 unique lot numbers including 3000314373, 3000314821, 3000320140, 3000333524, and 3000388588.
  3. If you are a healthcare provider using these systems, contact Maquet Cardiovascular, LLC to discuss the potential for fluid ingress and any necessary precautions or tool replacements.
  4. Contact your healthcare provider if you have concerns about a procedure that utilized these vessel harvesting tools.
  5. For further information or to report issues, contact the manufacturer at their Wayne, New Jersey facility or via their official customer service channels.
  6. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional questions regarding this safety alert.

Your Remedy Options

๐Ÿ“‹Other Action

Consultation and manufacturer instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: VasoView HemoPro 2 Endoscopic Vessel Harvesting System
Model / REF:
VH-4000
UPC Codes:
00607567700406
Lot Numbers:
All lot numbers within expiration
Product: VasoView HemoPro 2 with Vasoshield
Model / REF:
VH-4001
UPC Codes:
00607567700451
Lot Numbers:
All lot numbers within expiration
Product: VasoView HemoPro Endoscopic Vessel Harvesting System
Model / REF:
VH-3500
VH-3000-W
UPC Codes:
00607567701250
00607567700345
Lot Numbers (111):
3000314373
3000314821
3000316023
3000316024
3000316027
3000317501
3000317575
3000317576
3000318302
3000318901
3000320140
3000320141
3000320773
3000321483
3000321723
3000323214
3000324397
3000324409
3000325013
3000325249
3000325689
3000325776
3000328206
3000328561
3000328562
3000329723
3000330445
3000331131
3000331388
3000332428
3000332510
3000332993
3000333524
3000333829
3000333956
3000333967
3000334315
3000335670
3000336708
3000337272
3000339701
3000340534
3000341133
3000341675
3000342250
3000342251
3000343264
3000343266
3000344887
3000351187

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94700
Status: Active
Manufacturer: Maquet Cardiovascular, LLC
Sold By: Hospitals and surgical centers
Manufactured In: United States
Units Affected: 2 products (430,037 units; 37,186 units)
Distributed To: Nationwide
Agency Last Updated: July 16, 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.

Find an Attorney

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.