Recall Z-3073-2024 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Medtronic Neuromodulation
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
| Date | Sep 6, 2024 (initiated Jun 17, 2024) |
| Status | Open, Classified |
| Reason | A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup. |
| Root cause | Software change control |
| Action | 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 |
| Quantity | 211 devices |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.