Innsbruck, N/A, Austria
MED-EL Elektromedizinische Gereate, Gmbh recalls
2 recalls recorded since 2018, most recently on 18 April 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 18 April 2024
- Reason
- 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.
- Distribution
- US, Durham, NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2356-2024
- Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Terminated Class II Medical devices
- Recall started
- 16 October 2018
- Terminated
- 22 May 2020
- Reason
- Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2136-2019, Z-2137-2019, Z-2138-2019
- 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
- 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
- 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 com
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.