Advanced Bionics Recalls HiRes 90K Cochlear Implants Due to Loose Tools
Advanced Bionics is recalling 17 HiRes 90K cochlear implant devices with Helix Electrodes because of loose-fitting insertion tool assemblies.
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: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.
Plain-English summary
Advanced Bionics Corporation is recalling 17 units of the HiRes 90K cochlear implant system with Helix Electrodes (Model CI 1400-02H). The recall is due to loose-fitting insertion tool assemblies. The HiResolution Bionic Ear System is designed to provide useful hearing to individuals with severe to profound hearing loss.
The affected devices were distributed worldwide, including nationwide in the United States (specifically Illinois) and in Europe. The recall involves specific serial numbers listed in the agency documentation.
Consumers and healthcare providers with these specific devices should contact Advanced Bionics Corporation for further instructions on how to proceed with the recall.
The recalled product
- Product
- HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal…
- Manufacturer
- Advanced Bionics Corporation
- Hazard
- Affected units
- 17
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 (17)
- Serial Numbers: 351323
- 251153
- 350989
- 351226
- 350196
- 351136
- 350140
- 350201
- 351261
- 351264
- 351266
- 351269
- 351412
- 351415
- 351429
- 350157
- 351303.
Distribution
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