Reported Aug 14, 2019 · Terminated
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types
MED-EL Elektromedizinische Gereate, GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MED-EL Elektromedizinische Gereate, Gmbh · Furstenweg 77a · Innsbruck, N/A · N/A
Is this the product you have?
MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types
7 of 7 products
| # | Product as published |
|---|---|
| 1 | Mil000 CONCERTO PIN +FLEX28 |
| 2 | Mi1000 CONCERTO +FLEX28 |
| 3 | Mi1000 CONCERTO PIN +FLEXsoft |
| 4 | Mil000 CONCERTO +Standard |
| 5 | Mil000 CONCERTO +Medium |
| 6 | Mi1000 CONCERTO PIN +Standard |
| 7 | 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. |
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 Mil000 CONCERTO PIN +FLEX28, Serial Number 510312 2 Mi1000 CONCERTO +FLEX28, Serial Number 518214 3 Mi1000 CONCERTO PIN +FLEXsoft, Serial Number 531793 4 Mil000 CONCERTO +Standard, Serial Number 510079 5 Mil000 CONCERTO +Medium, Serial Number 532046 6 Mi1000 CONCERTO PIN +Standard, Serial Number 535616 7 M11000 CONCERTO +Compressed, Serial Number 538434 - Amount recalled
- 7 devices
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
This product could cause temporary or reversible health problems — stop using it.
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