Recall Z-2136-2019 ยท PGQ Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification
MED-EL Elektromedizinische Gereate, Gmbh
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. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part
| Date | Oct 16, 2018 |
| Status | Terminated |
| Reason | Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. |
| 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 de |
| Quantity | 7 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.