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.
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
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.
The hazard occurs when the controller does not have the correct firmware installed for the local language interface. This can cause confusion in device operation but does not pose a risk of injury or damage under normal use.
Users of Model 97745 controllers with Models 97715 and 97716 Intellis Neurostimulators in Korea and Turkey are most at risk. Affected units have specific serial numbers and UDI/DI codes.
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.
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.
The recall is because some units distributed in Korea and Turkey did not have the correct firmware installed to support the user interface in the local language.
Check your controller's serial number against the list provided in the recall notice to see if it is affected.
No safety risks are associated with this product. The hazard is limited to potential confusion in device operation due to incorrect language support.
We’ve drafted a message you can send Medtronic Neuromodulation to request your refund or repair — edit it as you like.
Subject: Recall Z-0354-2024 — Medtronic Neuromodulation Medtronic Neuromodulation Hello, I own a Medtronic Neuromodulation that is covered by recall Z-0354-2024 from Medtronic Neuromodulation. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
