Medtronic Neuromodulation: Medical Device Recall in 2021 - (Recall #: Z-1535-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 25, 2021

Date Posted: May 12, 2021

Recall Number: Z-1535-2021

Event ID: 87674

Reason for Recall:

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

Status: Ongoing

Product Quantity: 79,616 units

Code Information:

All serial numbers

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated