Medtronic Intellis Spinal Cord Stimulator — Class II medical device recall Z-0860-2021
Ongoing recall by Medtronic Neuromodulation, reported 2021-01-20, distributed nationwide. A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intel
| Recall number | Z-0860-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2020-11-12 |
| Classified | 2021-01-14 |
| Reported by FDA | 2021-01-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, JP |
| Quantity | 7,960 downloads |
| Reason classes | software |
| Model numbers | A710 |
Product
Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators (external and implantable) for pain therapy.
Reason for recall
A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
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-0860-2021. 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.