Z-0354-2024 Class II Ongoing
FDA device recall Z-0354-2024 was initiated by Medtronic Neuromodulation on Oct 19, 2023 and is designated Class II. Reason for recall: Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language. The recall status is ongoing. Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 29, 2023
- Initiation Date
- Oct 19, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Reason for Recall
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
Distribution Pattern
International distribution to the countries of S. Korea and Turkey.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0354-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026