Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1535-2021
Event ID87674
Event DescriptionIntellis 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 TypeDevices
DistributionWorldwide distribution.
Quantity79,616 units
Recall ReasonThere is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Device Classification20210512
Device Code InfoAll serial numbers
Center Classification Date20210506
Recall Initiation Date20210325
Recalling FirmMedtronic Neuromodulation
Initial Notification Letter
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