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Open, Classified

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.

FDA Recall Z-1535-2021 · Posted None

Recall StatusOpen, Classified
Product CodeLGW
Date Initiated2021-03-25
Product Quantity79,616 units

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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