Z-1368-2021Class II

A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model...

Name: Z-1368-2021 A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model...
Creator: Medtronic Neuromodulation
Published: 2021-03-09
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2021-03-09 / Open, Classified / root cause: software

FDA source

Medtronic Neuromodulation began a recall of A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version... on 2021-03-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1368-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-09
Posted: 2021-04-07
Recalling firm: Medtronic Neuromodulation
Product: 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.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Beginning 9-Mar-2021, Medtronic representatives began verbally notifications in order to inform impacted physicians of the issues and provide the mitigations outlined in the letters. Beginning 16-Mar-2021, Medtronic notified its consignees via mail, email, fax, and/or personal visit by Medtronic personnel. The notice described the problems and provided a workaround to use until a software update is available.
Quantity in commerce: 5332 downloads
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1368-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1368-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-07

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)