CLASS II ONGOING Device recall · Reported 14 Apr 2021 · FDA Enforcement Report

A610 Clinician Programmer Application recalled

Medtronic Neuromodulation is recalling A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming, distributed nationwide in the US. The recall was initiated on 9 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesversion 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

Quantity recalled5332 downloads

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-1368-2021
FDA event ID: 87569
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 9 Mar 2021
FDA classified: 7 Apr 2021
Reported: 14 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

9 Mar 2021	Recall initiated by company
7 Apr 2021	Classified by FDA	+29 days
14 Apr 2021	Published in enforcement report	+7 days

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

Reason for recall

There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Event log is full, the clinician programmer A610 Software application version 2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.

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

A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

Where it was distributed

Worldwide distribution - US Nationwide distribution in Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Malta, Netherlands, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom.

Nationwide Puerto Rico

Questions about this recall

Is A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming recalled?

Yes. Medtronic Neuromodulation recalled A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming on 9 Mar 2021. The recall is Class II and its status is Ongoing. Recall number Z-1368-2021.

Why was it recalled?

Which lots are affected?

version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 is approved for distribution in Europe only.

Where was it sold?

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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