Mi1260 SONATA 2 MEDIUM 38539Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09008737385392), received between Dec 19, 2024 and Jul 22, 2026 — classified as 2 malfunctions.

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 16, 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.

• MalfunctionJul 22, 2026Migration

  PATIENT UNDERWENT A REIMPLANTATION ON (b)(6) 2026 (NEW DEVICE: (b)(6)). FOLLOWING THE INTERVENTION, THE CLINICAL OUTCOME WAS NOT SATISFACTORY, AS TELEMETRY RESULTS RAISED CONCERNS REGARDING A POSSIBLE EXTRACOCHLEAR POSITION OF THE ELECTRODE ARRAY. DESPITE THESE FINDINGS, THE PATIENT PROCEEDED TO ACTIVATION ON (b)(6) 2026. DURING ACTIVATION SESSION, FITTING COULD NOT BE COMPLETED AS THERE WAS NO AUDITORY PERCEPTION IN ANY OF THE CHANNELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25905558 ↗
• MalfunctionDec 19, 2024Impedance Problem; Impedance Problem

  IN SITU MEASUREMENTS SHOWED FLUCTUATING IMPEDANCES OVER TIME. HEARING PERFORMANCE IS REPORTEDLY NOT AFFECTED. HOWEVER, THE USER HAS NO ORAL LANGUAGE SKILLS, MAKING IT DIFFICULT TO MEASURE CHANGES IN HEARING. RE-IMPLANTATION IS BEING CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20975116 ↗

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-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-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 Product
• 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. Mi1000 CONCE