CLASS II ONGOING Device recall · Reported 2 Aug 2023 · FDA Enforcement Report

A901 Communication Manager Application, used recalled

Medtronic Neuromodulation is recalling A901 Communication Manager Application, used in conjunction with the A710 Clinician. The recall was initiated on 21 Jun 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.

Quantity recalled2 clinician tablets

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-2226-2023
FDA event ID: 92530
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 21 Jun 2023
FDA classified: 21 Jul 2023
Reported: 2 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

21 Jun 2023	Recall initiated by company
21 Jul 2023	Classified by FDA	+30 days
2 Aug 2023	Published in enforcement report	+12 days

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

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..

Where it was distributed

International distribution to the countries of Israel and Serbia.

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058.

Where was it sold?

International distribution to the countries of Israel and Serbia.

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.

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