MED-EL is recalling 7 units of the Mi1250 SYNCHRONY 2 Cochlear Implant because a small number of devices may have a higher probability of a crack within the internal electronics substrate. This defect could result in a non-functional device, rendering the cochlear implant unusable for the patient. The recall affects three specific variants: FLEXSOFT S-Vector, FLEX28 S-Vector, and FLEX26 S-Vector. Consumers should contact their healthcare provider or the manufacturer immediately to discuss the status of their device.
A crack in the internal electronics substrate can lead to immediate or future device failure. If the internal electronics fail, the implant will stop functioning, resulting in a loss of hearing assistance for the user.
manufacturer or healthcare provider consultation
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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