Intellis Model 97755 Recharger — Class II medical device recall Z-1535-2021
Ongoing recall by Medtronic Neuromodulation, reported 2021-05-12. There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
| Recall number | Z-1535-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2021-03-25 |
| Classified | 2021-05-06 |
| Reported by FDA | 2021-05-12 |
| Quantity | 79,616 units |
| Model numbers | 97715, 97716, 97755 |
Product
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.
Reason for recall
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
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-1535-2021. 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.