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.
Reported: May 12, 2021 Initiated: March 25, 2021 #Z-1535-2021
Product Description
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 79,616 units
- Distribution
- Worldwide distribution.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Neuromodulation. Units affected: 79,616 units.
Why was this product recalled? ▼
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 12, 2021. Severity: Moderate. Recall number: Z-1535-2021.
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