Medtronic Neuromodulation recalls Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Recalled November 29, 2023 · FDA recall Z-0354-2024 · Medtronic Neuromodulation

Hazard

Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. · FDA Class II

Units

26 units

Sold at

International distribution to the countries of S. Korea and Turkey.

Description

Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.

Product

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Manufacturer(s)

Medtronic Neuromodulation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →