The Recall Desk
HighFDA (Devices)·Z-2136-2019·Announced 2019-08-14

MED-EL Mi1000 Cochlear Implant Recall Due to Helium Leak Test Failures

MED-EL is recalling seven Mi1000 CONCERTO cochlear implant devices because they were distributed despite failing helium-fine leak tests. The devices are intended for severely to profoundly hearing impaired individuals.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device distributed despite failing safety specifications (leak test), representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.

Plain-English summary

MED-EL Elektromedizinische Gereate, Gmbh is recalling seven units of the MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO. The recall covers specific implant types including the Mi1000 CONCERTO PIN +FLEX28, Mi1000 CONCERTO +FLEX28, and Mi1000 CONCERTO PIN +FLEXsoft, among others. The devices are 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.

The recall was initiated because the devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. The source text does not report any illnesses, injuries, or deaths associated with these devices.

The devices were distributed worldwide, including in the United States (California and Illinois) and in Argentina, Australia, Austria, Brazil, Bulgaria, China, France, Georgia, Korea, Poland, the Russian Federation, Spain, and Sweden. Consumers with these specific serial numbers should contact their healthcare provider or MED-EL for instructions on what to do next.

The recalled product

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
Manufacturer
MED-EL Elektromedizinische Gereate, Gmbh
Category
Medical Device — Cochlear Implant
Hazard
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by MED-EL Elektromedizinische Gereate, Gmbh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · MED-EL Elektromedizinische Gereate, Gmbh

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Same hazard · leak failure

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