MED-EL Mi1000 Cochlear Implant Recall Due to Helium Leak Test Failures
MED-EL is recalling seven Mi1000 CONCERTO cochlear implant devices because they were distributed despite failing helium-fine leak tests. The devices are intended for severely to profoundly hearing impaired individuals.
- 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
- Category
- Medical Device
- Distribution
- Distributed nationwide