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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/Home Healthcare

Medtronic A820 myPTM App Recalled for Slow Interaction with Implantable Pumps

Agency Publication Date: April 1, 2025
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Summary

Medtronic Neuromodulation is recalling approximately 4,365 units of its A820 myPTM software application, which is used by patients to manage their Medtronic SynchroMed Pump and Infusion Systems. This recall was issued because the app may take longer than expected to interact with the implanted pump, causing delays in monitoring or therapy adjustments. While Medtronic has received product complaints regarding this performance issue, no specific injuries have been reported. Consumers using this application should contact their healthcare provider or Medtronic for instructions on how to handle software interactions.

Risk

The software app may respond slowly when communicating with the implanted infusion pump, which could delay a patient's ability to manage their therapy or receive necessary medication. This slow interaction could lead to an interruption in treatment or delayed monitoring of the implant's status.

What You Should Do

  1. This recall involves version v.2x of the Medtronic A820 myPTM Software Application, which is used in conjunction with SynchroMed Pump and Infusion Systems.
  2. Check the version number of your software app in the application settings or look for UDI/DI 00763000632793 on any provided product documentation.
  3. Stop using the recalled software application.
  4. Contact your healthcare provider or Medtronic Neuromodulation to receive further instructions on how to manage your implanted pump during this recall or to arrange for a software correction.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional consumer safety information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: A820 myPTM Software Application
Variants: version v.2x
Model / REF:
A820
UDI:
00763000632793

Associated with Medtronic SynchroMed Pump and Infusion System.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96237
Status: Active
Manufacturer: Medtronic Neuromodulation
Sold By: Medtronic Neuromodulation; Authorized medical distributors
Manufactured In: United States
Units Affected: 4365 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.