CLASS II ONGOING Device recall · Reported 31 Jan 2024 · FDA Enforcement Report

Model A710 Intellis Clinician Programmer Application, version recalled

Medtronic Neuromodulation is recalling Model A710 Intellis Clinician Programmer Application, version 2.0.97. The recall was initiated on 19 Dec 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00763000520076, S/N: NPL1000519

Quantity recalled1 tablet

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0780-2024
FDA event ID: 93714
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 19 Dec 2023
FDA classified: 22 Jan 2024
Reported: 31 Jan 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 Dec 2023	Recall initiated by company
22 Jan 2024	Classified by FDA	+34 days
31 Jan 2024	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Model A710 Intellis Clinician Programmer Application, version 2.0.97

Where it was distributed

Germany

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI/DI 00763000520076, S/N: NPL1000519

Where was it sold?

Germany

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Medtronic Neuromodulation

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