PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: September 18, 2024 Initiated: June 17, 2024 #Z-3073-2024

Product Description

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.

Details

Recalling Firm
Medtronic Neuromodulation
Units Affected
211 devices
Distribution
US Nationwide distribution.
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.. Recalled by Medtronic Neuromodulation. Units affected: 211 devices.
Why was this product recalled?
A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 18, 2024. Severity: Moderate. Recall number: Z-3073-2024.