FDA Device recall Z-1129-2022
Percept PC 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 PC 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-1129-2022 |
| 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 PC 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; GTIN/UPN: 00763000420987; Serial number: NPI708734H; Expiration Date: 10/28/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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All Medtronic Neuromodulation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1129-2022%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.