---
title: "Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimula... — FDA record Z-0354-2024 | Is It on Recall"
description: "Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language."
url: https://isitonrecall.com/recall/fda-device-z-0354-2024-model-97745-controller-used-with-models-97715-and-97716-intellis-neurostimulators/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators — FDA record Z-0354-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 19, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
- **Reason**: Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
- **Classification**: Class II
- **Recalling firm**: Medtronic Neuromodulation
- **Quantity**: 26 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0354-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0354-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 00763000642297, Serial Numbers: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N; UDI/DI 00763000724436, Serial Numbers: NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160339N, NLD163010N, NLD160340N, NLD163011N |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

International distribution to the countries of S. Korea and Turkey.

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Nov 29, 2023
- **Recall initiation date**: Oct 19, 2023
- **Center classification date**: Nov 20, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0354-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Neuromodulation records](https://isitonrecall.com/brand/medtronic-neuromodulation/)