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MED-EL Elektromedizinische Gereate, Gmbh recalls MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of
Recalled August 14, 2019 · FDA recall Z-2138-2019 · MED-EL Elektromedizinische Gereate
Hazard
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. · FDA Class II
Units
1 device
Sold at
Worldwide distribution - US Nationwide in the states of California and Illinois. Countries of ARGENTINA, AUSTRALIA, AUSTRIA, BRAZIL, BULGARIA, CHINA, FRANCE, GEORGIA, KOREA, REPUBLIC OF, POLAND, RUSSIAN FEDERATION, SPAIN, SWEDEN.
Description
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
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.
Manufacturer(s)
MED-EL Elektromedizinische Gereate, Gmbh
Made in
Austria
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →