FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
- Recall number
- Z-2226-2023
- Recalling firm
- Medtronic Neuromodulation
- Product
- A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
- Status
- Open, Classified
- Initiated
- 2023-06-21
- Posted
- 2023-07-21
- Terminated
- not on file
- Reason
- When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
- Root cause
- Under Investigation by firm
- Action
- Only one of the two consignees received the notification since one of the consignees independently updated their tablet. On 6/22/2023, the notification dated June 2023 was issued to the consignee via visit by the sales representative. The notification described the issue and provided required actions which included: (1) Update the A901 Comm Manager application to version 1.0.1239 on the clinician programmer (tablet), serial #NPL3011706, using the instructions listed in Appendix A, Updating Clinician Programmer Software; (2) Complete the Customer Confirmation Form enclosed with the letter acknowledging that the consignee has received this information; and (3) Share this notice with all those who need to be aware of the issue within the organization and maintain a copy of it in the records.
- Quantity
- 2 clinician tablets
- Distribution
- International distribution to the countries of Israel and Serbia.
- Lot, serial or model codes
- Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LGW
- 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