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

MED EL Cochlear Implant System, PULSARci100 Standard recalled

Med-el Elektromedizinische Gereate is recalling MED EL Cochlear Implant System, PULSARci100 Standard, 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 codesSerial Number 202001

Quantity recalled1 device

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-2138-2019
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, 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.

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

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?

Serial Number 202001

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

Other products in this recall event

2 other products · FDA event 81683

This product is part of a recall event; the main page for the event is MED EL Cochlear Implant System, Mi1000 MED EL Concerto recalled.

Reported	Class	Recall	Company	Reason	Where
14 Aug 2019	CLASS II	MED EL Cochlear Implant System, Mi1000 MED EL Concerto recalled	Med-el Elektromedizinische Gereate	Packaging Defects	Nationwide
14 Aug 2019	CLASS II	MED EL Cochlear Implant System, SONATATIi100 recalled	Med-el Elektromedizinische Gereate	Packaging Defects	Nationwide

More recalls from Med-el Elektromedizinische Gereate

All 5

Reported	Class	Recall	Company	Reason	Where
24 Jul 2024Device	CLASS II	Mi1250 Synchrony recalled by MED-EL Elektromedizinische	Med-el Elektromedizinische Gereate	Device Malfunction	NC
14 Aug 2019Device	CLASS II	MED EL Cochlear Implant System, SONATATIi100 recalled	Med-el Elektromedizinische Gereate	Packaging Defects	Nationwide
14 Aug 2019Device	CLASS II	MED EL Cochlear Implant System, Mi1000 MED EL Concerto recalled	Med-el Elektromedizinische Gereate	Packaging Defects	Nationwide
8 Mar 2017Device	CLASS II	Sonnet Mini Battery Pack CableProduct Usage recalled	Med-el Elektromedizinische Gereate	Processing Deviation	Nationwide

Other Hearing Aids recalls

All 22

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Medline convenience kits: Discectomy Pack DYNJ86476B Ear recalled	Medline Industries	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	See RES for full list recalled by Medline Industries	Medline Industries	Sterility	Nationwide
6 May 2026Device	CLASS II	HiResolution" Bionic Ear System M Zn-Air Battery Pak recalled	Advanced Bionics	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Medline Convenience Kits: Chp Cochlear Supplement Cds recalled	Medline Industries	Sterility	Nationwide
4 Feb 2026Device	CLASS II	Medline medical procedure convenience kits labeled as recalled	Medline Industries	Device Malfunction	Nationwide