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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/Implants & Prosthetics

Medtronic Neuromodulation: DBS Lead with StimLoc Kit Recalled for Use By Date Label Discrepancy

Agency Publication Date: November 3, 2023
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Summary

Medtronic is recalling 14 units of the DBS Lead with StimLoc kit (Model 3387S-40), an electrical implantable device. The recall is due to a labeling error where the 'Use By Date' printed on the outer package does not match the date printed on the individual product label inside. This discrepancy could lead to the use of a device that has exceeded its shelf life, which may compromise the sterility or performance of the implant. Consumers should contact their healthcare provider or Medtronic to determine if their specific device is affected.

Risk

A discrepancy in expiration dates may result in the use of an expired medical device, which can lead to complications such as infection due to compromised sterility or device failure.

What You Should Do

  1. Identify if you have the affected product by checking for the LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40, with Serial Number VA2JV2V and UDI/DI 00763000274320.
  2. Check the 'Use By Date' (UBD) on both the outer packaging and the individual product label to see if there is a discrepancy.
  3. Contact your healthcare provider or Medtronic Neuromodulation directly to confirm if your unit is part of this recall and to receive further instructions.
  4. If you are a healthcare professional, do not use any affected units and follow the instructions provided in the notification letter sent by Medtronic.
  5. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

manufacturer or healthcare provider Consultation

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

Affected Products

Product: LEAD 3387S-40 STIMLOC DBS
Model / REF:
3387S-40
UPC Codes:
00763000274320
Lot Numbers:
Serial Number VA2JV2V

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93170
Status: Resolved
Manufacturer: Medtronic Neuromodulation
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 14 units
Distributed To: Missouri, Florida, Texas, Washington

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.