MED EL Cochlear Implant System — Class II medical device recall Z-2136-2019
Terminated recall by MED-EL Elektromedizinische Gereate, Gmbh, reported 2019-08-14, distributed nationwide. Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant stand
| Recall number | Z-2136-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MED-EL Elektromedizinische Gereate, Gmbh, Innsbruck, N/A, Austria |
| Recall initiated | 2018-10-16 |
| Classified | 2019-08-02 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BG, BR, CN, ES, FR, KR, PL, SE |
| Quantity | 7 devices |
| Reason classes | packaging |
| Serial numbers | 510079, 510312, 518214, 531793, 532046, 535616, 538434, M11000, MI1000, MIL000 |
Product
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO 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 for recall
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2136-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.