RecallRadar

FDA Device recall Z-0780-2024

Model A710 Intellis Clinician Programmer Application, version 2.0.97

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

AgencyFDA Device
Recall numberZ-0780-2024
ClassificationClass II
Statusongoing
Initiated2023-12-19
Published2024-01-31
Last updated2026-09-13 11:57 UTC
CompanyMedtronic Neuromodulation
Distributionn/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_infoUDI/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.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0780-2024%22

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