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RecallWatchMedical Device Safety
Class IIOngoingZ-1506-2025

Medtronic Neuromodulation recalls A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion…

Medtronic NeuromodulationMinneapolis, MN, United StatesReported Apr 9, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.

Lot / code information

version v.2x, UDI/DI 00763000632793

What the firm is doing

Medtronic issued an URGENT: MEDICAL DEVICE correction notice to its consignees on 02/28/2025 via email or US mail. The notice explained the issue and provided recommendations to temporarily mitigate the problem, and requested the following: Actions " Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. " Please provide a copy of the attached patient letter to your affected patients. " Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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