Medtronic Neuromodulation Recall 87674
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.
Medtronic Neuromodulation Recall 87674 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1535-2021 |
Event ID | 87674 |
Event 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. |
Product Type | Devices |
Distribution | Worldwide distribution. |
Quantity | 79,616 units |
Recall Reason | There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger. |
Device Classification | 20210512 |
Device Code Info | All serial numbers |
Center Classification Date | 20210506 |
Recall Initiation Date | 20210325 |
Recalling Firm | Medtronic Neuromodulation |
Initial Notification | Letter |
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