Percept PC Implantable Neurostimulator — Class II medical device recall Z-0612-2021
Terminated recall by Medtronic Neuromodulation, reported 2020-12-23, distributed nationwide. A software anomaly in the A620 Patient Programmer application was identified that results in failure to connec
| Recall number | Z-0612-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2020-11-19 |
| Classified | 2020-12-16 |
| Reported by FDA | 2020-12-23 |
| Terminated | 2023-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 12 devices |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000253363 |
| Serial numbers | NPI706941H, NPI706945H, NPI706952H, NPI706954H, NPI706955H, NPI706957H, NPI706962H, NPI706963H, NPI706987H, NPI706992H, NPI707000H, NPI707024H |
| Model numbers | B35200 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0612-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.