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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Maquet VasoView Harvesting Systems Recalled for Wire and Silicone Defects

Agency Publication Date: January 3, 2025
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Summary

Maquet Cardiovascular, LLC has recalled approximately 429,177 units of the VasoView HemoPro 2 and HemoPro 2 with VasoShield Endoscopic Vessel Harvesting Systems. These devices are used in minimally invasive surgeries to harvest blood vessels for bypass procedures. The recall follows reports that the device's heater wire may bend or detach, and the silicone coating on the tool's jaws may peel or come off during a procedure. No injuries have been reported at this time.

Risk

If the heater wire or silicone pieces detach while inside a patient, they could cause tissue damage, thermal injuries, or be left behind as foreign objects in the body, requiring additional surgery to remove.

What You Should Do

  1. This recall involves all unexpired lots of the VasoView HemoPro 2 (Model VH-4000) and VasoView HemoPro 2 with VasoShield (Model VH-4001) Endoscopic Vessel Harvesting Systems.
  2. Identify affected products by checking the model number and UDI-DI on the device packaging. Model VH-4000 has UDI-DI 00607567700406, and Model VH-4001 has UDI-DI 00607567700451.
  3. Stop using the recalled devices immediately and remove any unexpired inventory from surgical suites.
  4. Contact Maquet Cardiovascular, LLC or your authorized medical distributor to arrange for the return, replacement, or correction of the affected units.
  5. Call the FDA's consumer line at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or to report any adverse events related to this device.

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
Model / REF:
VH-4000
Lot Numbers:
All unexpired Lots
UDI:
00607567700406

Quantity: 418,076 units (326,608 US, 91,468 OUS). Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

Product: Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System
Model / REF:
VH-4001
Lot Numbers:
All unexpired Lots
UDI:
00607567700451

Quantity: 11,101 units US. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95908
Status: Active
Manufacturer: Maquet Cardiovascular, LLC
Sold By: Authorized medical distributors; Direct hospital sales
Manufactured In: United States
Units Affected: 2 products (418,076 units (326,608 US, 91,468 OUS); 11,101 units US)
Distributed To: Nationwide
Agency Last Updated: July 14, 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.