FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Model A710 Intellis Clinician Programmer Application, version 2.0.97
- Recall number
- Z-0780-2024
- Recalling firm
- Medtronic Neuromodulation
- Product
- Model A710 Intellis Clinician Programmer Application, version 2.0.97
- Status
- Open, Classified
- Initiated
- 2023-12-19
- Posted
- 2024-01-22
- Terminated
- not on file
- Reason
- Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
- Root cause
- Under Investigation by firm
- Action
- OUS communication to a single German consignee will be initiated via regionally approved methods beginning 19-Dec-2023. A field service technician will go to the site and reset the INS to resolve the issue.
- Quantity
- 1 tablet
- Distribution
- Germany
- Lot, serial or model codes
- UDI/DI 00763000520076, S/N: NPL1000519
- 510(k) numbers
- not on file
- PMA numbers
- ["P840001"]
- 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