Recall archive / FDA device enforcement
Model A710 Intellis Clinician Programmer Application, version 2.0.97 — FDA record Z-0780-2024
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 Dec 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 A710 Intellis Clinician Programmer Application, version 2.0.97
- Reason
- Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
- Classification
- Class II
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1 tablet
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0780-2024
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 00763000520076, S/N: NPL1000519 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Germany
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 31, 2024
- Recall initiation date
- Dec 19, 2023
- Center classification date
- Jan 22, 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.