Percept PC BrainSense Implantable Neurostimulator — Class II medical device recall Z-1129-2022
Ongoing recall by Medtronic Neuromodulation, reported 2022-06-01, distributed nationwide. The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient progr
| Recall number | Z-1129-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2022-03-30 |
| Classified | 2022-05-24 |
| Reported by FDA | 2022-06-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JP, LU, NL, NO, PL, PT, SE, SK, TH, ZA |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00763000420987 |
| Serial numbers | NPI708734H |
| Model numbers | B35200 |
| Expiration dates | 2022-10-28 |
Product
Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
Reason for recall
The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
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-1129-2022. 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.