FDA recall Z-3073-2024

Medtronic Neuromodulation · Class II · device

Product

Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.

Reason for recall

A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2024-06-17
Report date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3073-2024