Z-1506-2025Class II

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

Name: Z-1506-2025 A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System
Creator: Medtronic Neuromodulation
Published: 2025-01-09
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2025-01-09 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System on 2025-01-09. FDA classified it as Class II and gives the reason as "Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1506-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-09
Posted: 2025-04-01
Recalling firm: Medtronic Neuromodulation
Product: A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
FDA root cause: Under Investigation by firm
Action: 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 [email protected]. For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.
Quantity in commerce: 4365 units
Distribution: 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.
Product codes and lots: version v.2x, UDI/DI 00763000632793

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1506-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1506-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-04-09	2025-04-01

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)