Recall archive / FDA device enforcement
Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator — FDA record Z-1691-2024
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 Mar 28, 2024. 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
- Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
- Reason
- inability to reprogram one device
- Classification
- Class II
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1691-2024
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 00643169781719 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of UK.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- May 8, 2024
- Recall initiation date
- Mar 28, 2024
- Center classification date
- Apr 26, 2024
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.