FDA Device recall Z-0998-2022
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q…
- FDA Device
- Class II
- ongoing
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q… by Medtronic Neuromodulation, citing there is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0998-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-28 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300
Reason
There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.
Identifiers
| code_info | a) Model Numbers: 1) TH90Q01, UDI-Device Identifier (GTIN/UPN) 00763000582470, Serial Numbers: NPF0000074, NPF00000…a) Model Numbers: 1) TH90Q01, UDI-Device Identifier (GTIN/UPN) 00763000582470, Serial Numbers: NPF0000074, NPF0000075, NPF0000096, NPF0000097, NPF0000109, NPF0000197, NPF0000238, NPF0000263, NPF0000264, NPF0000270, NPF0000271, NPF0000284, NPF0000292, NPF0000379, NPF0000414, NPF0000422, NPF0000440, NPF0000458, NPF0000463, NPF0000480, NPF0000501, NPF0000515, NPF0000516, NPF0000517, NPF0000519, NPF0000537, NPF0000555, NPF0000618, NPF0000656, NPF0000691, NPF0000715, NPF0000784, NPF0000786, NPF0000828, NPF0000889, NPF0000908, NPF0000913, NPF0000915, NPF0000930, NPF0000931, NPF0001006, NPF0001045, NPF0001057, NPF0001058, NPF0001059, NPF0001060, NPF0001130, NPF0001135, NPF0001136, NPF0001154, NPF0001199, NPF0001267, NPF0001391, NPF0001403, NPF0001458, NPF0001485, NPF0001492, NPF0001493, NPF0001498, NPF0001502, NPF0001511, NPF0001620, NPF0001674, NPF0001713, NPF0001716, NPF0001758, NPF0001797, NPF0001824, NPF0001841, NPF0001868, NPF0001879, NPF0001893, NPF0001894, NPF0001900, NPF0001928, N |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0998-2022%22
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