Mi1250 SYNCHRONY 2 PIN FLEX20 37174Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09008737371746), received between Sep 28, 2022 and Sep 29, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (P000025); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER COMPLAINED OF A CHANGE IN SOUND QUALITY AND A SENSATION OF A TICKLING IN HIS RIGHT EAR CANAL. THE SOUND QUALITY IN THE RIGHT EAR HAS BEEN REPORTED AS VERY HIGH-PITCHED WITH A BUZZING QUALITY. ANYWAY THE USER STILL FEELS THAT HEARING IS BETTER WITH THE DEVICE THAN WITHOUT IT. THE ELECTRODE ARRAY WAS THEN VISUALISED IN THE USER'S EAR CANAL, WHERE AN EXTRUSION IS SUSPECTED. THE USER WILL VISIT THE IMPLANTING SURGEON AND A CT WILL BE PERFORMED.

  Patient problems: Tissue Breakdown

  MAUDE report 15501076 ↗
• MalfunctionSep 28, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER COMPLAINED OF A CHANGE IN SOUND QUALITY AND A SENSATION OF A TICKLING IN HIS RIGHT EAR CANAL. THE SOUND QUALITY IN THE RIGHT EAR HAS BEEN REPORTED AS VERY HIGH-PITCHED WITH A BUZZING QUALITY. ANYWAY THE USER STILL FEELS THAT HEARING IS BETTER WITH THE DEVICE THAN WITHOUT IT. THE ELECTRODE ARRAY WAS THEN VISUALISED IN THE USER'S EAR CANAL. ACCORDING TO THE IMPLANT REGISTRATION CARD A FULL INSERTION OF THE FLEX20 ARRAY WAS NOT ACHIEVED AND 1 CHANNEL WAS LEFT EXTRA-COCHLEAR. THE USER WILL VISIT THE IMPLANTING SURGEON AND A CT WILL BE PERFORMED.

  Patient problems: Tissue Breakdown

  MAUDE report 15500334 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000025. One submission often covers many models, so check the product and lot details in each record.

• Z-2356-2024 · Apr 18, 2024 · Open, Classified
  Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
• Z-2136-2019 · Oct 16, 2018 · Terminated
  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. Mi100
• Z-2137-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard
• Z-2138-2019 · Oct 16, 2018 · Terminated
  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 toge