Recall archive / FDA device enforcement
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application.. — FDA record Z-2226-2023
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 Jun 21, 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
- A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
- Reason
- When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
- Classification
- Class II
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 2 clinician tablets
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2226-2023
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 | Serial numbers NPL3011706 and NPL3016791, UDI-DI 643169738058. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the countries of Israel and Serbia.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 2, 2023
- Recall initiation date
- Jun 21, 2023
- Center classification date
- Jul 21, 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.