Class 2 Device Recall Cochlear Implant

• Date Initiated by Firm: October 16, 2018
• Create Date: August 02, 2019
• Recall Status: Terminated on May 22, 2020
• Recall Number: Z-2136-2019
• Recall Event ID: 81683
• PMA Number: P000025
• Product Classification: Cochlear implant with combined electrical stimulation and acoustic amplification - Product Code PGQ
• 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 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: MED-EL Elektromedizinische Gereate, Gmbh; Furstenweg 77a; Innsbruck Austria
• Manufacturer Reason for Recall: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
• FDA Determined Cause: Employee error
• Action: Med-EL initially notified customers who had not yet implanted the affected devices on about 10/16/2018 via telephone call and followed up with an "Urgent-Medical Device Field Safety Notice (FSN)." The notice instructed customers to not implant the device if still available in inventory. Customers who had implanted the device were notified on about 11/27/2018 via telephone call and followed up with an "Urgent-Medical Device Field Safety Notice (FSN)." The notice instructed customers to immediately inform affected clinics of the recall and the long term risk. MED-EL does not recommend a device explantation, as the device may work as intended for years before the electronics may become affected by humidity ingress. Ultimately, accumulation of internal moisture may cause complete failure of the device. Should any uncomfortable or painful sensation be experienced, please stop immediately using the device and contact MED-EL or your local support center for immediate support. MED-EL recommends regular implant checks at least once a year to check the implant status. Additionally the customers were requested to respond to the FSN and confirm receipt.
• Quantity in Commerce: 7 devices
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = PGQ and Original Applicant = MED-EL CORP.