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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 6 Pro Recalled for Incorrect Packaging and Labeling

Agency Publication Date: November 2, 2023
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Summary

Maquet Cardiovascular, LLC has recalled one lot of the Vasoview 6 Pro (VV6) Endoscopic Vessel Harvesting System, Model VH-2400. This recall was initiated because the device was mistakenly placed inside an outer box that displays artwork and illustrations for a different device, the Vasoview Hemopro 2 (HP2). Although the inner label and instructions for use correctly identify the product as the Vasoview 6 Pro, the misleading outer box could cause confusion for medical staff during surgical preparation. This recall affects Lot 3000313857, which was distributed in several U.S. states and Canada.

Risk

The mismatch between the outer box artwork and the actual device inside may lead healthcare professionals to select or prepare the wrong medical tool for a procedure. This confusion could result in delays during surgery or improper device use, though the internal product labeling remains accurate.

What You Should Do

  1. Identify if you have the affected product by checking for Vasoview 6 Pro (VV6) Endoscopic Vessel Harvesting System, Model VH-2400, specifically looking for Lot 3000313857 and UDI-DI 00607567700239.
  2. Inspect the outer packaging to see if it mistakenly displays artwork or illustrations for the Vasoview Hemopro 2 (HP2) instead of the Vasoview 6 Pro (VV6).
  3. Contact your healthcare provider or Maquet Cardiovascular, LLC at their Wayne, New Jersey headquarters to receive instructions on how to handle or return affected units.
  4. If you have further questions regarding this recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit the FDA medical device recalls website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and contact

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

Affected Products

Product: Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System
Model / REF:
VH-2400
UPC Codes:
00607567700239
Lot Numbers:
3000313857

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93297
Status: Active
Manufacturer: Maquet Cardiovascular, LLC
Sold By: Maquet Cardiovascular, LLC
Manufactured In: United States
Distributed To: Alabama, Arkansas, California, Florida, Georgia, Indiana, Kentucky, Michigan, New Jersey, Oklahoma, Pennsylvania, Tennessee, Texas

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.