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.
This recall is currently active, issued March 25, 2021. It was issued by Medtronic Neuromodulation.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- March 25, 2021
- Recall Number
- Z-1535-2021
- Quantity
- 79,616 units
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
Distribution
Worldwide distribution.
Lot / Code Info
All serial numbers
Root Cause
Under Investigation by firm
Action Taken
Beginning 25-Mar-2021, Medtronic began notifying physicians in the US and consignees OUS via mail, email, fax, and/or personal visit by Medtronic personnel. In the US, each implanting physician was sent the medical device correction letter, the patient quick guide, and the customer confirmation form. Outside the US, the medical device correction letter, the patient quick guide, and the customer confirmation form were sent to the healthcare facilities. Additionally, on an ongoing basis, the patient quick guide will be provided with each replacement recharger.