Recall Z-3073-2024— Medtronic Neuromodulation

Class II · Ongoing

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2024-06-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.. Reason: A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup..

Recalling firm
Medtronic Neuromodulation
Classification
Class II
Status
Ongoing
Initiated
2024-06-17
Firm location
Minneapolis, MN, United States

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.