SONATATI100 +COMPRESSED 04915Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 09008737049157), received between Jul 6, 2018 and Sep 8, 2026 — classified as 16 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Output Problem” (23 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671367 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  The user received an implant in 2021. She developed meningitis following the implant and was born with Johanson-Blizzard syndrome. Re-implantation is considered.

  Patient problems: Meningitis

  MAUDE report 50671351 ↗
• MalfunctionJun 3, 2026Impedance Problem

  THE RECIPIENT REPORTED PAIN AROUND THE COIL, WHICH WAS NOT RELATED TO THE MAGNET STRENGTH AND BEGAN APPROXIMATELY TWO MONTHS AGO. WHEN THE AUDIO PROCESSOR (AP) WAS REMOVED, THE PAIN PERSISTED AND RADIATED TOWARD THE EYE REGION. THEN THE RECIPIENT BEGAN EXPERIENCING A METALLIC TASTE IN THE MOUTH. DUE TO THE PAIN, THE RECIPIENT OFTEN NEEDED TO REMOVE THE AP. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Taste Disorder

  MAUDE report 25371133 ↗
• MalfunctionApr 28, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: Head Injury

  MAUDE report 25015369 ↗
• MalfunctionJan 26, 2026Impedance Problem

  THE USER HAS NO MORE HEARING SENSATION WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24175880 ↗
• MalfunctionJul 30, 2025Impedance Problem; Impedance Problem

  THE RECIPIENT VISITED THE CLINIC WHERE AFFECTED CHANNELS WERE SEEN. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22663372 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE RECIPIENT HAD RECURRENT MENINGITIS SINCE 2020, FOR ABOUT 7 OR 8 TIMES, AND THE CLINIC SUGGESTED TO REMOVE THE IMPLANT FIRST FOR FURTHER TREATMENT OF MENINGITIS. AFTER THE INITIAL IMPLANTATION IN 2019, THE RECIPIENT OBTAINED HEARING BENEFITS FROM THE DEVICE. CEREBROSPINAL FLUID METAGENOMIC TESTING FOR PATHOGENS: STREPTOCOCCUS PNEUMONIAE; PURULENT MENINGITIS IS CLINICALLY DIAGNOSED. THE RECIPIENT HAS BEEN EXPLANTED. RE-IMPLANTATION IS CONSIDERED AT A LATER DATE.

  Patient problems: Meningitis

  MAUDE report 22517322 ↗
• MalfunctionJun 5, 2025Impedance Problem; Impedance Problem

  ON (B)(6) 2025, THE PARENT REPORTED THAT THE RECIPIENT HAD NOT BEEN HEARING SOUNDS WITH THE DEVICE FOR ABOUT TWO WEEKS. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148319 ↗
• MalfunctionMay 15, 2025Impedance Problem; Impedance Problem

  THE PARENTS REPORTED A DECLINE IN HEARING PERFORMANCE WITH THE RIGHT-SIDE DEVICE IN (B)(6) 2025. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024108 ↗
• MalfunctionApr 29, 2025Circuit Failure; Impedance Problem; Circuit Failure; Impedance Problem

  THE PARENT REPORTED A DECLINE IN HEARING PERFORMANCE WITH THE DEVICE IN (B)(6) 2024. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924176 ↗
• InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER HAS EXPERIENCED RECURRING EPISODES OF SWELLING IN THE AREA OF THE INTERNAL COMPONENT. THE FIRST EPISODE OCCURRED AROUND 2 YEARS AGO, IN 2022. THE RECIPIENT HAS BEEN EXPLANTED.

  Patient problems: Swelling/ Edema

  MAUDE report 20703625 ↗
• MalfunctionOct 17, 2024Impedance Problem; Impedance Problem

  THE PARENT REPORTED IN (B)(6) 2024 THAT THE RECIPIENT WAS SUDDENLY UNABLE TO HEAR SOUNDS WITH THE DEVICE. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20469971 ↗
• MalfunctionAug 7, 2024Malposition of Device; Migration; Malposition of Device; Migration

  THE RECIPIENT HAD MENINGITIS AND HAD A LOT OF OSSIFICATION AT THE TIME OF IMPLANTATION. A COMPRESSED ELECTRODE WAS PLACED, HOWEVER, A GOOD INSERTION COULD NOT BE ACHIEVED LEAVING 2 CHANNELS OUT OF COCHLEA, ALTHOUGH THE DOCTOR TRIED DIFFERENT APPROACHES. THE RECIPIENT WAS NOT USING THE DEVICE MUCH DUE TO FACIAL STIMULATION. AN APPOINTMENT WITH THE DOCTOR HAS BEEN SCHEDULED FOR (B)(6) 2024 TO EVALUATE FURTHER PROCEEDINGS.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 19925810 ↗
• InjuryMay 21, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  RECURRENT EPISODE OF POST AURAL WOUND INFECTION AND PARTIAL EXTRUSION OF THE DEVICE THAT LED TO EXPLANTATION. IN ADDITION, THE COMPLETE ELECTRODE ARRAY WAS FOUND OUTSIDE THE COCHLEAR AT THE TIME OF EXPLANTATION. EXPLANTATION HAS BEEN PERFORMED ON (B)(6) 2024.

  Patient problems: Tissue Breakdown

  MAUDE report 19358413 ↗
• MalfunctionFeb 27, 2024Impedance Problem; Impedance Problem

  THE USERS HEARING PERFORMANCE WITH THE DEVICE WAS REPORTEDLY AFFECTED. FURTHER PROCEEDINGS ARE UNKNOWN.

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

  MAUDE report 18785916 ↗
• MalfunctionDec 12, 2023Impedance Problem; Impedance Problem

  THE PARENTS REPORTED THAT IN EARLY (B)(6) 2023, A DECLINE IN HEARING PERFORMANCE OF THE RECIPIENT WAS OBSERVED. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18308456 ↗
• MalfunctionAug 8, 2023Impedance Problem; Impedance Problem

  THE RECIPIENT HAS EFFECTIVE USE OF THE RIGHT SIDE DEVICE AND WAS ABLE TO UNDERSTAND SENTENCES IN SILENCE (77%) AND IN NOISE (51%), WITHOUT PERFORMANCE DETERIORATION. HOWEVER, HE REPORTED THAT WHEN HE USES THE AUDIO PROCESSOR (AP) ON THE RIGHT, HE FELT LIKE A STIMULATION, A "RESOUND OF THE SOUND". WHEN THE AP WAS TURNED OFF, THE PROBLEM WAS NOT REPORTED. ANOTHER AP WAS ALREADY TESTED AND RESULTED IN THE SAME OUTCOME. FURTHER PROCEEDINGS ARE UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 17478245 ↗
• MalfunctionMay 15, 2023Migration; Migration

  THE USER DID NOT HAVE GOOD BENEFIT IN EARLY 2023. REPORTEDLY, THE FIRST FITTING HAPPENED IN 2021 BUT THE USER COULD NOT GET GOOD BENEFIT FROM THE CI SYSTEM AT THAT TIME AND THE PARENTS DECIDED TO GET THEIR DAUGHTER TREATED WITH LANGUAGE REHABILITATION TRAINING. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16928740 ↗
• MalfunctionFeb 3, 2023Impedance Problem; Impedance Problem

  ON 11-DEC-2022 THE REHABILITATION CENTER REPORTED THAT THE USER MIGHT HAVE HAD A TRAUMA. IN SITU TESTING SHOWED AFFECTED CHANNELS AND POOR HEARING PERFORMANCE WITH THE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16288758 ↗
• MalfunctionJan 24, 2023Impedance Problem; Impedance Problem

  THE MOTHER FOUND THAT THE USER_S REACTION FOR THE SOUND WAS NOT LIKE BEFORE. WHEN FITTING PERFORMED, AFFECTED CHANNELS WERE SEEN. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16232682 ↗
• MalfunctionNov 24, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THERE WAS NO RELATED EVENT. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15860632 ↗
• MalfunctionNov 16, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER AND HER MOTHER VISITED THE CLINIC APPROXIMATELY BEGINNING OF NOVEMBER REPORTING THAT THE USER STOPPED HEARING WITH THE DEVICE. IT WAS INITIALLY THOUGHT THAT THERE WAS A PROBLEM WITH THE EXTERNAL DEVICE. CT IMAGING ARE CONSIDERED TO BE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 15803060 ↗
• MalfunctionOct 25, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER EXPERIENCED A HEAD TRAUMA ON (B)(6) 2022, WHICH CAUSED HIS EAR CANAL TO BLEED AND COULD NOT HEAR SOUNDS WITH THE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15664948 ↗
• MalfunctionSep 13, 2022Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  IT WAS REPORTED THAT IN MID (B)(6) 2021 THE USER HAD SUDDENLY STOPPED HEARING WITH THE DEVICE. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15408919 ↗
• MalfunctionAug 30, 2022Output Problem; Output Problem

  IN DECEMBER OF 2021 POOR AUDITORY RESPONSE WITH THE DEVICE WAS OBSERVED. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15318495 ↗

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. Mi1000 CONCE
• 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