CLASS II ONGOING Device recall · Reported 12 May 2021 · FDA Enforcement Report

Intellis Model 97755 Recharger - Product Usage: designed to charge recalled

Medtronic Neuromodulation is recalling Intellis Model 97755 Recharger - Product Usage: designed to charge. The recall was initiated on 25 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers

Quantity recalled79,616 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1535-2021
FDA event ID: 87674
Recalling firm: Medtronic Neuromodulation, Minneapolis, MN
Classification: Class II
Status: Ongoing
Recall initiated: 25 Mar 2021
FDA classified: 6 May 2021
Reported: 12 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

25 Mar 2021	Recall initiated by company
6 May 2021	Classified by FDA	+42 days
12 May 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All serial numbers

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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