FDA Device recall Z-1535-2021
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with A…
- FDA Device
- Class II
- ongoing
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class II recall of Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with A… by Medtronic Neuromodulation, citing there is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1535-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-25 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
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
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1535-2021%22
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