Model B35200 — Class II medical device recall Z-0418-2022
Ongoing recall by Medtronic Neuromodulation, reported 2022-01-05, distributed nationwide. During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive
| Recall number | Z-0418-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2021-10-19 |
| Classified | 2021-12-27 |
| Reported by FDA | 2022-01-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JP, KR, LU, NL, NO, PL, PT, SE, SI, SK, TH |
| Quantity | 10,006 units |
| UPC / GTIN / UDI-DI | 00763000253363, 00763000311483, 00763000311490, 00763000311506, 00763000311513, 00763000311520, 00763000311537, 00763000311544, 00763000311551, 00763000311582, 00763000311599, 00763000311605, 00763000311643, 00763000353971, 00763000420987, 00763000524821, 00763000524838, 00763000524845, 00763000524883 |
| Serial numbers | NPI701986H, NPI701987H, NPI701988H, NPI701989H, NPI701990H, NPI701991H, NPI701992H, NPI701993H, NPI701994H, NPI701995H, NPI701996H, NPI701997H, NPI701998H, NPI701999H, NPI702000H, NPI702001H, NPI702002H, NPI702005H, NPI702007H, NPI702008H, NPI702009H, NPI702010H, NPI702011H, NPI702012H, NPI702014H and 475 more |
| Model numbers | B35200 |
Product
Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Reason for recall
During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
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-0418-2022. 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.