FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
- Recall number
- Z-1506-2025
- Recalling firm
- Medtronic Neuromodulation
- Product
- A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
- Status
- Open, Classified
- Initiated
- 2025-01-09
- Posted
- 2025-04-01
- Terminated
- not on file
- Reason
- Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
- 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 neuro.quality@medtronic.com. For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.
- Quantity
- 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.
- Lot, serial or model codes
- version v.2x, UDI/DI 00763000632793
- 510(k) numbers
- not on file
- PMA numbers
- P860004
- Product code
- LKK
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28