Recall Z-1535-2021— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2021-03-25. FDA's recall record names no specific 510(k) clearance for this event. 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: There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-03-25
- Firm location
- Minneapolis, MN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.