InterStim — Class II medical device recall Z-1774-2019
Ongoing recall by Medtronic Neuromodulation, reported 2019-06-19, distributed nationwide. There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clini
| Recall number | Z-1774-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2019-05-15 |
| Classified | 2019-06-12 |
| Reported by FDA | 2019-06-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, DK, ES, FI, FR, GB, IT, NL, NO |
| Quantity | 13,979 units |
| UPC / GTIN / UDI-DI | 00763000058005, 00763000187231, 00763000192259, 00763000192266, 00763000192273, 00763000192280, 00763000192297, 00763000192303, 00763000192310 |
| Model numbers | 3023, 3058, A510 |
Product
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).
Reason for recall
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
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-1774-2019. 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.