Mi1250 SYNCHRONY 2 FLEX20 S-Vector Magnet 39549Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09008737395490), received between Jun 20, 2024 and Jun 20, 2024 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE USER SUFFERED A HEAD TRAUMA. REPORTEDLY 4 CHANNELS WERE FOUND WITH HIGH IMPEDANCE AND THE CHILD HAD NO HEARING PERCEPTION WHEN STIMULATING THESE AFFECTED CHANNELS. AS THE USER WAS ONLY RECENTLY IMPLANTED IT IS DIFFICULT TO SAY IF HIS BENEFIT IS BETTER OR WORSE THAN BEFORE. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19573366 ↗

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