# FDA recall Z-1774-2019

> **Medtronic Neuromodulation** · Class II · device recall initiated 2019-05-15.

## 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).

## Distribution

Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands

## Key facts

- **Recall number:** Z-1774-2019
- **Recalling firm:** Medtronic Neuromodulation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-05-15
- **Report date:** 2019-06-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2019

## Citation

> AI Analytics. FDA recall Z-1774-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1774-2019. Source: US FDA. Licensed CC0.

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