CLASS II Device recall · Reported 11 Oct 2023 · FDA Enforcement Report

Restore Clinician Programmer Application recalled

Medtronic Neuromodulation is recalling Restore Clinician Programmer Application, distributed nationwide in the US. The recall was initiated on 17 Jul 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersion 1.0.4232, UDI-DI 00763000273668.

Quantity recalled2,408 devices

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-2657-2023
FDA event ID: 92798
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 17 Jul 2020
FDA classified: 29 Sep 2023
Reported: 11 Oct 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

17 Jul 2020	Recall initiated by company
29 Sep 2023	Classified by FDA	+1169 days
11 Oct 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

The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.

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

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

Where it was distributed

Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.

Nationwide

Questions about this recall

Is Restore Clinician Programmer Application recalled?

Yes. Medtronic Neuromodulation recalled Restore Clinician Programmer Application on 17 Jul 2020. The recall is Class II and its status is Terminated. Recall number Z-2657-2023.

Why was it recalled?

Which lots are affected?

Version 1.0.4232, UDI-DI 00763000273668.

Where was it sold?

Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.

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 21 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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Reported	Class	Recall	Company	Reason	Where
3 Jun 2026Device	CLASS II	Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled	Medtronic Neuromodulation	Other	Nationwide
3 Jun 2026Device	CLASS II	Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled	Medtronic Neuromodulation	Other	Nationwide
21 Jan 2026Device	CLASS II	A71200 Vanta" Clinician Programmer Application (CP App) recalled	Medtronic Neuromodulation	Device Malfunction	Nationwide
31 Dec 2025Device	CLASS II	Restore Clinician Programmer Application (CP App) recalled	Medtronic Neuromodulation	Device Malfunction	Nationwide
7 May 2025Device	CLASS II	Enhanced Verify Evaluation Handset (CFN HH90130FA) recalled	Medtronic Neuromodulation	Device Malfunction	Nationwide

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