Z-1535-2021Class II

Intellis Model 97755 Recharger -

Name: Z-1535-2021 Intellis Model 97755 Recharger -
Creator: Medtronic Neuromodulation
Published: 2021-03-25
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2021-03-25 / Open, Classified

FDA source

Medtronic Neuromodulation began a recall of Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology... on 2021-03-25. FDA classified it as Class II and gives the reason as "There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1535-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-03-25
Posted: 2021-05-06
Recalling firm: Medtronic Neuromodulation
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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 79,616 units
Distribution: Worldwide distribution.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1535-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1535-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-05-12	2021-05-06

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)