Z-2137-2019Class II

MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100...

Name: Z-2137-2019 MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100...
Creator: MED-EL Elektromedizinische Gereate, Gmbh
Published: 2018-10-16
License: https://open.fda.gov/license/

Med-el Elektromedizinische Geraete, GmbH / initiated 2018-10-16 / Terminated / root cause: manufacturing process

FDA source

MED-EL Elektromedizinische Gereate, Gmbh began a recall of MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100... on 2018-10-16. FDA classified it as Class II and gives the reason as "Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2137-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-16
Posted: 2019-08-02
Terminated: 2020-05-22
Recalling firm: Med-el Elektromedizinische Geraete, GmbH
Product: 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 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 code: PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
Reason for recall: Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Root cause tag: manufacturing process
FDA root 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: 10 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.
Product codes and lots: a. SONATAti100 FLEXsoft, Serial Number 150489; b. SONATAti100 H Standard, Serial Numbers 146714, 164324; c. SONATAti100 Standard, Serial Numbers 145179, 217623, 144443, 145228, 158919, 147748, 223013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2137-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2136-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2137-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2138-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02

Product code PGQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)