MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL — Class II medical device recall Z-0998-2022
Completed recall by Medtronic Neuromodulation, reported 2022-05-04, distributed nationwide. There is a software anomaly with the InterStim X Clinician software application with results in the data enter
| Recall number | Z-0998-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2022-02-28 |
| Classified | 2022-04-22 |
| Reported by FDA | 2022-05-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,005 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00763000058005, 00763000187231, 00763000433871, 00763000517182, 00763000517199, 00763000582470, 00763000582487 |
| Serial numbers | NPF0000060, NPF0000061, NPF0000063, NPF0000064, NPF0000070, NPF0000073, NPF0000074, NPF0000075, NPF0000085, NPF0000086, NPF0000088, NPF0000089, NPF0000091, NPF0000092, NPF0000095, NPF0000096, NPF0000097, NPF0000099, NPF0000100, NPF0000102, NPF0000103, NPF0000105, NPF0000107, NPF0000109, NPF0000110 and 475 more |
| Model numbers | A51300, A52300 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0998-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.