Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MED EL Cochlear Implant System Recalled by MED-EL Elektromedizinische Gereate, Gmbh Due to Devices were distributed despite the Helium-fine leak test...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact MED-EL Elektromedizinische Gereate, Gmbh directly.
Affected Products
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product Usage: The SONATATIi100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.
Quantity: 10 devices
Why Was This Recalled?
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About MED-EL Elektromedizinische Gereate, Gmbh
MED-EL Elektromedizinische Gereate, Gmbh has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report