MED-EL Elektromedizinische Gereate, Gmbh: Medical Device Recall in 2019 - (Recall #: Z-2138-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 16, 2018

Date Posted: August 14, 2019

Recall Number: Z-2138-2019

Event ID: 81683

Reason for Recall:

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

Status: Terminated

Product Quantity: 1 device

Code Information:

Serial Number 202001

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated