FDA Device recall Z-0354-2024
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators by Medtronic Neuromodulation, citing units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0354-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-19 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
Product
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Reason
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Identifiers
| code_info | UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD1720…UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N; UDI/DI 00763000724436, Serial Numbers: NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0354-2024%22
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