Medtronic Intellis Neurostimulator Controller firmware misconfiguration affects user interface language
Medtronic Neuromodulation is recalling 26 units of Model 97745 Controller distributed to South Korea and Turkey with incorrect firmware, resulting in user interface displayed in English rather than local language.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device recall with no reported injuries or hospitalizations. The hazard is firmware misconfiguration resulting in user interface language localization failure, which is a usability/configuration issue rather than an inherent safety defect.
Plain-English summary
Medtronic Neuromodulation is recalling 26 units of the Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators. These controllers were distributed to South Korea and Turkey.
The recalled units were installed with incorrect firmware, resulting in the user interface not being supported in the local language. Users of these devices experience the interface displayed in English rather than in the appropriate local language for the region.
The affected units can be identified by their UDI codes and serial numbers as specified in the FDA recall documentation. Additional information and support regarding this recall are available from the FDA and Medtronic Neuromodulation.
The recalled product
- Product
- Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
- Manufacturer
- Medtronic Neuromodulation
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
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