The Recall Desk

FDA (Devices) recall action 81683

MED-EL Elektromedizinische Gereate, Gmbh recalled 3 products on 2019-08-14

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2019-08-14
Critical
0
Units
18

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2019-08-14

    MED-EL SONATAti100 Cochlear Implant Recall for Leak Test Failures

    MED-EL is recalling 10 SONATAti100 cochlear implants because they failed helium-fine leak tests. The devices were distributed despite not meeting specifications.

    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
    Category
    Distribution
    2 states
  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2019-08-14

    MED-EL PULSARci100 Cochlear Implant Recalled for Leak Test Failures

    MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.

    Product
    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 e
    Category
    Distribution
    2 states