Recall archive / FDA device enforcement
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators — FDA record Z-0354-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 26 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0354-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of S. Korea and Turkey.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 29, 2023
- Recall initiation date
- Oct 19, 2023
- Center classification date
- Nov 20, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.