Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic Handset with Communicator Recalled by Medtronic Neuromodulation Due to A subset of the handsets within the kit...

Date: June 17, 2024
Company: Medtronic Neuromodulation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.

Affected Products

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

Quantity: 211 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic Neuromodulation

Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report