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Lower risk Medical device recall · FDA · Published October 19, 2023

Medtronic Neuromodulation Model 97745 Controller: Incorrect Firmware for Local Language

Medtronic Neuromodulation recalls Model 97745 controllers used with specific neurostimulators in Korea and Turkey due to incorrect firmware installation for local language interfaces. Affected units have unique serial numbers and UDI/DI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0354-2024Medical deviceMedtronic Neuromodulation ›
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Contact the company

Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568
✎ GovInfoNow plain-language explainer

Medtronic Neuromodulation is recalling Model 97745 controllers used with Models 97715 and 97716 Intellis Neurostimulators sold in Korea and Turkey. The recall is because some units lacked the correct firmware to support the user interface in local languages, which could lead to confusion in device operation. Read more at govinfonow.com/recall/57049-medtronic-neuromodulation-model-97745-controller-incorrect-firmware-for-local-language.

Source Summary by GovInfoNow · govinfonow.com/recall/57049-medtronic-neuromodulation-model-97745-controller-incorrect-firmware-for-local-language · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0354-2024

Cite this page

“Medtronic Neuromodulation Model 97745 Controller: Incorrect Firmware for Local Language.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57049-medtronic-neuromodulation-model-97745-controller-incorrect-firmware-for-local-language. Based on FDA recall #Z-0354-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0354-2024%22&limit=1).

The Food and Drug Administration announced on Oct. 19, 2023, that Medtronic Neuromodulation is voluntarily recalling Model 97745 Controllers used with Models 97715 and 97716 Intellis Neurostimulators due to incorrect firmware for local language support in Korea and Turkey.

How to tell if you have it

  • Brand: Medtronic Neuromodulation
  • Product: Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
  • 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

The hazard

Units distributed in Korea and Turkey lacked the correct firmware to support the user interface in the local language.

Context

GovInfoNow's records show Medtronic Neuromodulation has had 45 other recalls since Aug. 9, 2017. Other recent recalls include Medtronic Pocket Adaptor Kits with Incorrect Use-By Dates recalled on May 13, 2026, and Medtronic SynchroMed Flex Infusion Software Issue recalled on April 8, 2026.

How to tell if you have this one

Check if your Model 97745 controller is paired with Models 97715 or 97716 Intellis Neurostimulators. Affected units have specific serial numbers listed in the recall notice or UDI/DI codes provided.

  • Brand
    Medtronic Neuromodulation
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Controller Serial Numbers

    Look for serial numbers on the controller: NLD172060N, NLD142952N, NLD172064N, NLD142947N, NLD142942N, NLD172061N, NLD172062N, NLD172063N, NLD172066N, NLD160337N, NLD163006N, NLD142943N, NLD163007N, NLD142944N, NLD163008N, NLD160338N, NLD163009N, NLD160340N, NLD163011N.

How this recall unfolded

Recall timeline

FDA published this recall 41 days after the firm started it.

1. Firm started the recall: Oct 19, 202312. FDA classified it Class II: Nov 20, 202323. Published in FDA’s Enforcement Report: Nov 29, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0354-2024 (October 19, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0354-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA