Mi1250 SYNCHRONY 2 PIN FLEX20 S-Vector Magnet 39548Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09008737395483), received between Feb 24, 2026 and Sep 29, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Impedance Problem” (1 report).

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, 2026Migration

  The user only has minimal sound impressions with the device. There was a re-insertion on the next day as the electrode slipped out of the cochlea.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931400 ↗
• MalfunctionFeb 24, 2026Impedance Problem

  USER HAS NO SPEECH UNDERSTANDING WITH THE IMPLANTED DEVICE ON THE LEFT SIDE (BILATERALLY IMPLANTED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427399 ↗

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-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
• 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