# FDA recall Z-1535-2021

> **Medtronic Neuromodulation** · Class II · device recall initiated 2021-03-25.

## 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.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-1535-2021
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-25
- **Report date:** 2021-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2021

## Citation

> AI Analytics. FDA recall Z-1535-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1535-2021. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*