FDA Device recall Z-2137-2019
MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft
- FDA Device
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft by Med El Elektromedizinische Gereate, citing devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2137-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-16 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Med El Elektromedizinische Gereate |
| Distribution | US |
Product
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.
Reason
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Identifiers
| code_info | a. SONATAti100 FLEXsoft, Serial Number 150489; b. SONATAti100 H Standard, Serial Numbers 146714, 164324; c. S…a. SONATAti100 FLEXsoft, Serial Number 150489; b. SONATAti100 H Standard, Serial Numbers 146714, 164324; c. SONATAti100 Standard, Serial Numbers 145179, 217623, 144443, 145228, 158919, 147748, 223013. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2137-2019%22
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