Envoy Medical Recalls Esteem Programmers for Noise Interference
Envoy Medical is voluntarily correcting 44 Esteem Programmers to reduce susceptibility to noise interference.
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 source describes a voluntary correction to reduce susceptibility to noise interference without reporting any injuries, illnesses, or deaths, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Envoy Medical Corporation is conducting a voluntary correction of 44 Esteem Programmers, which are part of the Esteem Totally Implantable Hearing System. The affected units include the Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, as well as the ISA and Commander software packages that run on a laptop personal computer.
The recall is being conducted to reduce the devices' susceptibility to noise interference. The affected products were distributed worldwide, including in the United States (specifically in AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX) and Germany.
Consumers who possess these specific programmer units or software packages should contact Envoy Medical Corporation for further instructions regarding the voluntary correction.
The recalled product
- Product
- Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on a laptop personal computer.
- Manufacturer
- Envoy Medical Corporation
- Hazard
- Affected units
- 44
Distribution
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