FDAClass IIMay 12, 2021

Intellis recall

Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with AdaptiveStim…

Why was Intellis recalled?

There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All serial numbers

Product
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators:  Intellis with AdaptiveStim…
Recalling firm
Medtronic Neuromodulation
Quantity
79,616 units
Distribution
Worldwide distribution.
Recall date
May 12, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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