CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report

A71200 Vanta" Clinician Programmer Application (CP App) recalled

Medtronic Neuromodulation is recalling A71200 Vanta" Clinician Programmer Application (CP App), distributed nationwide in the US. The recall was initiated on 3 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesversion 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.

Quantity recalled7123

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-1043-2026
FDA event ID: 98097
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 3 Dec 2025
FDA classified: 9 Jan 2026
Reported: 21 Jan 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Medical Software

Timeline

3 Dec 2025	Recall initiated by company
9 Jan 2026	Classified by FDA	+37 days
21 Jan 2026	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

Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

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

A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

Where it was distributed

Worldwide - US Nationwide distribution.

Nationwide

Questions about this recall

Is A71200 Vanta" Clinician Programmer Application (CP App) recalled?

Yes. Medtronic Neuromodulation recalled A71200 Vanta" Clinician Programmer Application (CP App) on 3 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1043-2026.

Why was it recalled?

Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

Which lots are affected?

version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.

Where was it sold?

Worldwide - US Nationwide distribution.

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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3 Jun 2026Device	CLASS II	Medtronic Pocket Adaptor Kit for Deep Brain Stimulation recalled	Medtronic Neuromodulation	Other	Nationwide
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