Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Mod

FDA device recall Z-3073-2024 · posted 2024-09-06 · Open, Classified

Recall details

Recalling firm

Medtronic Neuromodulation

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.

Action taken

The recalling firm issued letters dated June 2024 beginning 6/17/2024 to the Medtronic Field Service Representatives to notify consignees and retrieve a subset of the InterStim Smart Programmer and Communicator Kits (TH90Q01). The notification informed the Field Service Representatives of the Field Corrective Action and provided instruction on notifying the consignees and retrieving the device(s). Beginning on June 17, 2024, US initiated communications and notifications dated June 2024 were physically hand-delivered to each consignee with the impacted device(s). The letter described the issue and provided Required Customer Actions, which included completing and signing the Customer Confirmation form acknowledging receipt of the notification and sharing the notice with all that needed to be aware. An appendix was enclosed which listed the serial numbers of the affected products.

Root cause

Software change control

Status

Open, Classified

Product code

EZW

Quantity affected

211 devices

Distribution

US Nationwide distribution.

Date initiated

2024-06-17

Date posted

2024-09-06

Location

Minneapolis, MN