FDA Device recall Z-1128-2022
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
- FDA Device
- Class II
- ongoing
- Published 2022-06-01
On 2022-06-01 the FDA classified a Class II recall of Percept BrainSense Implantable Neurostimulator (INS), Model B35200 by Medtronic Neuromodulation, citing the Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1128-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-30 |
| Published | 2022-06-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Reason
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
Identifiers
| code_info | Model: B35200; Expiration Range: 11/14/2021-02/14/2024; GTIN/UPN: 00763000253363, Serial Numbers: NPI702363H, NPI702456…Model: B35200; Expiration Range: 11/14/2021-02/14/2024; GTIN/UPN: 00763000253363, Serial Numbers: NPI702363H, NPI702456H, NPI702503H, NPI702504H, NPI702543H, NPI702551H, NPI702575H, NPI703408H, NPI703516H, NPI703553H, NPI703635H, NPI703969H, NPI703972H, NPI704070H, NPI704084H, NPI704097H, NPI704103H, NPI704104H, NPI704106H, NPI704107H, NPI704117H, NPI704118H, NPI704120H, NPI704121H, NPI704122H, NPI704123H, NPI704124H, NPI704125H, NPI704126H, NPI704127H, NPI704128H, NPI704129H, NPI704130H, NPI704131H, NPI704132H, NPI704133H, NPI704134H, NPI704135H, NPI704136H, NPI704137H, NPI704138H, NPI704140H, NPI704145H, NPI704146H, NPI704147H, NPI704152H, NPI704153H, NPI704156H, NPI704157H, NPI704158H, NPI704159H, NPI704160H, NPI704161H, NPI704163H, NPI704164H, NPI704165H, NPI704166H, NPI704172H, NPI704173H, NPI704178H, NPI704181H, NPI704182H, NPI704183H, NPI704184H, NPI704185H, NPI704186H, NPI704189H, NPI704190H, NPI704192H, NPI704193H, NPI704194H, NPI704195H, NPI704196H, NPI704197H, NPI704198H, NP |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1128-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.