A901 Communication Manager Application — Class II medical device recall Z-2226-2023
Ongoing recall by Medtronic Neuromodulation, reported 2023-08-02. When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System
| Recall number | Z-2226-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2023-06-21 |
| Classified | 2023-07-21 |
| Reported by FDA | 2023-08-02 |
| Countries outside the US | IL, RS |
| Quantity | 2 clinician |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00643169738058 |
| Serial numbers | NPL3011706, NPL3016791 |
Product
A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2226-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.