FDA Device recall Z-0780-2024
Model A710 Intellis Clinician Programmer Application, version 2.0.97
- FDA Device
- Class II
- ongoing
- Published 2024-01-31
On 2024-01-31 the FDA classified a Class II recall of Model A710 Intellis Clinician Programmer Application, version 2.0.97 by Medtronic Neuromodulation, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0780-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-19 |
| Published | 2024-01-31 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
Product
Model A710 Intellis Clinician Programmer Application, version 2.0.97
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.
Identifiers
| code_info | UDI/DI 00763000520076, S/N: NPL1000519 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation - Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001
FDA Device · Class II · 2026-06-03 · Medtronic Neuromodulation - Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A C…
FDA Device · Class II · 2026-05-20 · Medtronic Neuromodulation - A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200
FDA Device · Class II · 2026-01-21 · Medtronic Neuromodulation - Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US…
FDA Device · Class II · 2025-12-31 · Medtronic Neuromodulation
All Medtronic Neuromodulation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0780-2024%22
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