FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Clinician Programmer Application (CPA) model A610 Clinician Software Application
- Recall number
- Z-0201-2022
- Recalling firm
- Medtronic Neuromodulation
- Product
- Clinician Programmer Application (CPA) model A610 Clinician Software Application
- Status
- Open, Classified
- Initiated
- 2021-09-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- A software anomaly may occur with the clinician programmer application.
- Root cause
- Software design
- Action
- A customer letter was distributed to impacted customers beginning September 16, 2021. Customers are asked to contact their Medtronic representative or Medtronic Technical Services at 1-800-707-0933 to troubleshoot should they experience the software anomaly issue.
- Quantity
- 3302
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, New Zealand, Canada, Europe, India, Japan, Korea, Middle East, Latin America, Africa, SE Asia and China.
- Lot, serial or model codes
- Clinician Programmer Application (CPA) model A610 version 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081
- 510(k) numbers
- not on file
- PMA numbers
- ["P960009"]
- Product code
- MHY
- 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