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

FDA device recall Z-1506-2025 · posted 2025-04-01 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

LKK

Quantity affected

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

Date initiated

2025-01-09

Date posted

2025-04-01

Location

Minneapolis, MN