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MED-EL Elektromedizinische Gereate Recalls
5 recalls on record · March 8, 2017 to July 24, 2024 · Medical Devices
Recalls by year
17
19
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 24, 2024Medical DevicesFDA
MED-EL Elektromedizinische Gereate, Gmbh recalls Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vect
Hazard: 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.
August 14, 2019Medical DevicesFDA
MED-EL Elektromedizinische Gereate, Gmbh recalls MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of
Hazard: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
August 14, 2019Medical DevicesFDA
MED-EL Elektromedizinische Gereate, Gmbh recalls MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft;
Hazard: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
August 14, 2019Medical DevicesFDA
MED-EL Elektromedizinische Gereate, Gmbh recalls MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO
Hazard: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
March 8, 2017Medical DevicesFDA
MED-EL Elektromedizinische Gereate, Gmbh recalls SONNET Mini Battery Pack CableProduct Usage: The SONNET Mini Battery Pack Cable is part of the SONNET Mini Battery Pack
Hazard: Unit Defect: Firm inspection revealed units did not have the compartment lock firmly welded to the housing.