Reported May 12, 2021 · Ongoing
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable…
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
97755 | Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology |
97715 | Implanted Neurostimulator Intellis |
97716 | Implanted Neurostimulator. |
- Lot codes and dates
- All serial numbers
- Amount recalled
- 79,616 units
Why it was recalled
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
This product could cause temporary or reversible health problems — stop using it.
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