A610 Clinician Programmer — Class II medical device recall Z-2427-2024
Ongoing recall by Medtronic Neuromodulation, reported 2024-07-31, distributed nationwide. Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
| Recall number | Z-2427-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2024-05-15 |
| Classified | 2024-07-24 |
| Reported by FDA | 2024-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BO, BR, CA, CH, CN, CO, CR, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IS, IT, JO, JP, KR, KW, LB, LT, LU, LV, MA, MT, MX, MY, NL, NO, NZ, PE, PH, PK, PL, PT, SA, SE, SG, SI, SK, TH, TW, UY, VN, ZA |
| Quantity | 18,010 units |
| UPC / GTIN / UDI-DI | 00613994544940, 00613994544957, 00613994604446, 00613994604453, 00613994604460, 00613994604477, 00613994604484, 00613994604491, 00613994761057, 00613994761064, 00643169090866, 00643169093270, 00643169864207, 00643169864214, 00643169936584, 00643169936607, 00643169963269, 00643169963276, 00643169963283, 00643169963313, 00643169963320, 00763000100346, 00763000100353, 00763000111847, 00763000111854 and 25 more |
| Serial numbers | 00613994544940, 00613994544957, 00613994604446, 00613994604453, 00613994604460, 00613994604477, 00613994604484, 00613994604491, 00613994761057, 00613994761064, 00643169090866, 00643169093270, 00643169864207, 00643169864214, 00643169936584, 00643169936607, 00643169963269, 00643169963276, 00643169963283, 00643169963313, 00643169963320, 00763000100346, 00763000100353, 00763000111847, 00763000111854 and 475 more |
| Model numbers | 37602, 37603, 64001, 64002, B35200, B35300 |
Product
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1
Reason for recall
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
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-2427-2024. 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.