Percept PC BrainSense recallZ-0612-2021 · Medtronic Neuromodulation · initiated Nov 19, 2020
Class II Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-0612-2021
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 19, 2020
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 12 devices
- Product code
- MHY
- Distribution
- US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
Product description
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.
Code information (models, lots, serial numbers)
Model Number: B35200; GTIN: 00763000253363; Serial Numbers: NPI706941H, NPI707024H, NPI707000H, NPI706992H, NPI706963H, NPI706962H, NPI706987H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Percept™ PC BrainSense™ B35200Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)3 recalls1 death280 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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