Mi1260 SONATA 2 COMPRESSED 38540Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09008737385408), received between May 15, 2024 and Mar 17, 2025 — 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 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.

• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RECIPIENT SUFFERED FROM REDNESS AT THE IMPLANT AREA SINCE (B)(6) 2024. THE REDNESS THEN TURNED INTO SWELLING. IN (B)(6) 2024, THE SKIN WAS CORRECTED WITH REVISION FOR IMPLANT SITE EXPOSURE. IN EARLY 2025 THE INFECTION RE-OCCURRED. ANTIBIOTIC TREATMENT AND CREAMS THINNED THE SKIN. THE RECIPIENT WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 21617837 ↗
• MalfunctionMay 15, 2024Impedance Problem; Impedance Problem

  ACCORDING TO THE DISTRIBUTOR, NO TRAUMA WAS REPORTED. IN SITU TESTING SHOWED AFFECTED CHANNELS. FURTHERMORE, THE RECIPIENT HAS A COCHLEAR MALFORMATION; COCHLEAR HYPOPLASIA WITH A SINGLE TURN OF THE COCHLEA AND THE ENTRANCE OF THE ROUND WINDOW IS OSSIFIED, AND AUDITORY NERVE HYPOPLASIA. ACCORDING TO RECIPIENTS FAMILY, SHE SHOWED REACTION TO SOUND AND LOCALIZATION. RE-IMPLANTATION IS SCHEDULED FOR (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19318508 ↗

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 Product
• 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. Mi1000 CONCE