FDA recall Z-0354-2024

Medtronic Neuromodulation · Class II · device

Product

Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators

Reason for recall

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

Distribution

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

Key facts

Status
Ongoing
Initiation date
2023-10-19
Report date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0354-2024