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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 Vessel Harvesting Systems Recalled for Component Failure

Agency Publication Date: July 11, 2024
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Summary

Maquet Cardiovascular, LLC is recalling approximately 3,063 units of the Vasoview Hemopro and Hemopro 2 Endoscopic Vessel Harvesting Systems after 27 complaints regarding a straightened C-Ring wire and incorrect spacing between the ring and the harvesting tool. These systems are used by surgical teams to harvest blood vessels for bypass procedures. The defect could lead to technical difficulties or unintended tissue contact during surgery, although no adverse events or injuries have been reported to date. Affected models include VH-3500, VH-4000, and VH-4001 distributed throughout the United States and several international locations.

Risk

The C-Ring wire can straighten due to an insufficient bend radius, causing the harvesting tool and C-Ring to be closer than intended. This mechanical failure can compromise the surgical procedure's precision and potentially lead to vessel damage or increased surgical time.

What You Should Do

  1. Identify if your facility has the affected Vasoview Hemopro Endoscopic Vessel Harvesting Systems by checking for UDI-DI 00607567700345 (Model VH-3500) or UDI-DI 00607567700406 (Model VH-4000) and 00607567700451 (Model VH-4001).
  2. Verify the lot numbers against your inventory: 3000371260, 3000378288, 3000362934, 3000371798, 3000378554, 3000372477, 3000378950, 3000376542, 3000380314, 3000377320, or 3000380847.
  3. If you identify affected units, contact your healthcare provider or Maquet Cardiovascular, LLC immediately for specific instructions regarding the use or return of these devices.
  4. Contact Maquet Cardiovascular, LLC (a subsidiary of Getinge) at their New Jersey headquarters via the distributor address at 45 Barbour Pond Dr, Wayne, NJ 07470-2094 to discuss replacement or corrective actions.
  5. For additional information or to report concerns, contact the FDA at 1-888-463-6332 or visit 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 HEMOPRO Endoscopic Vessel Harvesting System
Model / REF:
VH-3500
UPC Codes:
00607567700345
Lot Numbers:
3000371260
3000378288
3000362934
3000371798
3000378554
3000372477
3000378950
3000376542
3000380314
3000377320
3000380847
Product: VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System
Model / REF:
VH-4000
VH-4001
UPC Codes:
00607567700406
00607567700451
Lot Numbers:
3000371260
3000378288
3000362934
3000371798
3000378554
3000372477
3000378950
3000376542
3000380314
3000377320
3000380847

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94802
Status: Active
Manufacturer: Maquet Cardiovascular, LLC
Sold By: Hospital suppliers; Medical device distributors
Manufactured In: United States
Units Affected: 2 products (600 units; 2463 units units US /330 units OUS)
Distributed To: Nationwide

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.