A820 myPTM Software Application associated with Medtronic… recallZ-1506-2025 · Medtronic Neuromodulation · initiated Jan 9, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
FDA root cause category: Under Investigation by firm
What the company 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 [email protected]. For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.
Recall details
- Recall number
- Z-1506-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 9, 2025
- Posted by the FDA
- Apr 1, 2025
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 4365 units
- Product code
- LKK
- FDA submissions
- P860004
- 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 description
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Code information (models, lots, serial numbers)
version v.2x, UDI/DI 00763000632793
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA A820Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall0 reports
Other devices under the same FDA submission
50 devices cleared under P860004 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall7 deaths4,929 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls5 deaths4,303 reports
- SYNCHROMED ® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths4,119 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls10 deaths3,054 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths3,084 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls1 death2,588 reports
- SynchroMed® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths2,291 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall3 deaths2,242 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall4 deaths1,964 reports
- SynchroMed® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths1,920 reports
- SYNCHROMED™ III 8667-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 death1,937 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths1,766 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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