Z-0612-2021Class II

Percept PC Implantable Neurostimulator (INS) -

Name: Z-0612-2021 Percept PC Implantable Neurostimulator (INS) -
Creator: Medtronic Neuromodulation
Published: 2020-11-19
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2020-11-19 / Terminated / root cause: software

FDA source

Medtronic Neuromodulation began a recall of Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated... on 2020-11-19. FDA classified it as Class II and gives the reason as "A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0612-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-19
Posted: 2020-12-16
Terminated: 2023-04-03
Recalling firm: Medtronic Neuromodulation
Product: Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
Root cause tag: software
FDA root cause: Software design
Action: Beginning November 19, 2020 accounts impacted by this issue were verbally notified to quarantine affected product. Beginning November 25, 2020 a recall notification letter and retrieval instructions titled "URGENT: MEDICAL DEVICE RECALL A620 Patient Programmer issue with specific Percept" PC Neurostimulators" was hand delivered to impacted accounts by Medtronic Representatives.
Quantity in commerce: 12 devices
Distribution: US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
Product codes and lots: Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0612-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0612-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-16

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)