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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

Medtronic Perfusion Systems: DLP Vessel Cannulae Recalled for Incorrect Labeling

Agency Publication Date: March 19, 2024
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Summary

Medtronic Perfusion Systems is recalling 4,343 units of its DLP Vessel Cannulae (Model REF 30000) because three specific lots were distributed with incorrect labeling. This labeling error may cause confusion regarding the product's specifications or proper use during medical procedures. These devices are used in surgical settings, and consumers should contact their healthcare provider or Medtronic to determine if their device is affected.

Risk

Incorrect labeling on a surgical vessel cannula can lead to the use of an improper device size or type during a procedure, potentially causing surgical delays or complications during perfusion. While no specific injuries have been reported in this notice, the error poses a risk to patient safety during critical cardiac or vascular surgeries.

What You Should Do

  1. Identify if you have the affected Medtronic DLP Vessel Cannula by checking the packaging for Model Number REF 30000 and UDI/DI 20613994646211.
  2. Specifically check for the following three affected lot numbers: 2023020890, 202305C126, or 2023020889.
  3. If you identify an affected product, contact your healthcare provider or Medtronic Perfusion Systems at 7611 Northland Dr N, Brooklyn Park, MN to receive further instructions on how to handle the mislabeled units.
  4. Healthcare facilities should isolate any unused products from these specific lots to prevent their use in surgical procedures.
  5. Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Corrective action for mislabeled medical devices

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

Affected Products

Product: Medtronic DLP Vessel Cannula
Model / REF:
REF 30000
UPC Codes:
20613994646211
Lot Numbers:
2023020890
202305C126
2023020889

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94068
Status: Active
Manufacturer: Medtronic Perfusion Systems
Sold By: Medtronic Perfusion Systems; Hospital supply chains
Manufactured In: United States
Units Affected: 4343 units
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.

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.