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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

Medtronic Neuromodulation: SynchroMed II Infusion Pump Recalled for Memory Data Corruption

Agency Publication Date: October 21, 2024
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Summary

Medtronic Neuromodulation has recalled one SynchroMed II Infusion Pump (Product Number 8637-20) with serial number NGP004814H. The device was recalled because internal data corruption in the pump memory can cause system errors and make it impossible for medical providers to read or adjust the pump's settings using an interrogation device. This single unit was distributed specifically in the state of Mississippi.

Risk

If the pump memory becomes corrupted, it may fail to communicate with the doctor's programmer or provide inaccurate information about the pump's status. This could result in a delay or loss of therapy, which for an implanted infusion pump can lead to the return of underlying symptoms or serious health complications from medication withdrawal.

What You Should Do

  1. Check your medical records or device identification card for the SynchroMed II Infusion Pump, Product Number: 8637-20, Serial Number: NGP004814H, and GTIN: 00643169630505.
  2. If you have this specific implanted device, contact your healthcare provider immediately to discuss your therapy and the status of your pump.
  3. Contact Medtronic Neuromodulation for further instructions and information regarding this recall.
  4. Call the FDA's consumer hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: SynchroMed II Infusion Pump
Model / REF:
8637-20
UPC Codes:
00643169630505
Lot Numbers:
Serial Number: NGP004814H

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95419
Status: Active
Manufacturer: Medtronic Neuromodulation
Sold By: authorized medical distributors
Manufactured In: United States
Units Affected: 1 unit
Distributed To: Mississippi

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.