FDA recall Z-1535-2021

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.

Reason for recall

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

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-03-25

Report date

2021-05-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1535-2021