MED-EL Elektromedizinische Gereate, Gmbh

5 recalls •

• Categories: Implants & Prosthetics

Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

Class I - Dangerous

A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

Apr 18, 2024 Implants & Prosthetics View Details →

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.

Class I - Dangerous

Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Oct 16, 2018 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Oct 16, 2018 Implants & Prosthetics Nationwide View Details →

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.

Class I - Dangerous

Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Oct 16, 2018 Implants & Prosthetics Nationwide View Details →

SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack, which is an external battery pack used to power one MED-EL SONNET control unit. It can be worn on the upper body or the hip using different SONNET Mini Battery Pack Cable lengths to connect the SONNET Mini Battery Pack to one processor unit.

Class I - Dangerous

Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.

Oct 25, 2016 Implants & Prosthetics Nationwide View Details →