Model 97745 Controller used with Models 97715 and 97716 Intellis… — Class II medical device recall Z-0354-2024
Ongoing recall by Medtronic Neuromodulation, reported 2023-11-29. Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user int
| Recall number | Z-0354-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2023-10-19 |
| Classified | 2023-11-20 |
| Reported by FDA | 2023-11-29 |
| Countries outside the US | KR, TR |
| Quantity | 26 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000642297, 00763000724436 |
| Serial numbers | NLD142942N, NLD142943N, NLD142944N, NLD142947N, NLD142952N, NLD160337N, NLD160338N, NLD160339N, NLD160340N, NLD163006N, NLD163007N, NLD163008N, NLD163009N, NLD163010N, NLD163011N, NLD172060N, NLD172061N, NLD172062N, NLD172063N, NLD172064N, NLD172066N |
| Model numbers | 97715, 97716, 97745 |
Product
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Reason for recall
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
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-0354-2024. 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.