CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

MED EL Cochlear Implant System, SONATATIi100 recalled

MED-EL Elektromedizinische Gereate is recalling MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a, distributed nationwide in the US. The recall was initiated on 16 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa. 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.

Quantity recalled10 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2137-2019
FDA event ID: 81683
Recalling firm: MED-EL Elektromedizinische Gereate, Innsbruck, N/A
Classification: Class II
Status: Terminated
Recall initiated: 16 Oct 2018
FDA classified: 2 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hearing Aids

Timeline

16 Oct 2018	Recall initiated by company
2 Aug 2019	Classified by FDA	+290 days
14 Aug 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide California Georgia Illinois

Questions about this recall

Is MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a recalled?

Yes. MED-EL Elektromedizinische Gereate recalled MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a on 16 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-2137-2019.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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25 Feb 2026Device	CLASS II	Medline Convenience Kits: Chp Cochlear Supplement Cds recalled	Medline Industries	Foreign Material	Nationwide
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