MED-EL Elektromedizinische Gereate, Gmbh: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Agency Publication Date: August 2, 2019

Affected Products

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 compatibl

a. Mil000 CONCERTO PIN +FLEX28, Serial Number 510312; b. Mi1000 CONCERTO +FLEX28, Serial Number 518214; c. Mi1000 CONCERTO PIN +FLEXsoft, Serial Number 531793; d. Mil000 CONCERTO +Standard, Serial Number 510079; e. Mil000 CONCERTO +Medium, Serial Number 532046; f. Mi1000 CONCERTO PIN +Standard, Serial Number 535616; g. M11000 CONCERTO +Compressed, Serial Number 538434

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 p

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.

Product: MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 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

Serial Number 202001

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81683

Status: Resolved

Manufacturer: MED-EL Elektromedizinische Gereate, Gmbh

Manufactured In: Austria

Units Affected: 3 products (7 devices; 10 devices; 1 device)

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Sources: FDA iRES · Raw API Response

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Affected Products

Serial Number 202001