SONATATI100 +FLEX28 08361Recalls & reported problems

Summary

The FDA's MAUDE database contains 427 adverse event reports that list this exact device (DI 09008737083618), received between Jul 6, 2018 and Sep 22, 2026 — classified as 139 injuries, 288 malfunctions.

The most frequently reported specific device problem is “Output Problem” (235 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. 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 25 most recent of 427 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Impedance Problem

  A hearing decline was noted in late August 2026. The user has been re-implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854871 ↗
• MalfunctionSep 15, 2026Impedance Problem

  Reported a progressive decline in the user's hearing over the past two months, despite the external device functioning properly. During programming, elevated channels were identified, raising concerns about implant performance. The user had 3 incidents of head trauma that occurred both before and after the decline in hearing performance.

  Patient problems: Head Injury

  MAUDE report 50770612 ↗
• InjuryAug 25, 2026Impedance Problem

  The parent reported scalp swelling and redness following head impact in May this year. Hearing performance with the CI deteriorated significantly.The user has been re-implanted.

  Patient problems: Head Injury

  MAUDE report 50431115 ↗
• MalfunctionAug 19, 2026Impedance Problem

  The user noticed a gradual decline in hearing benefit with the device. The clinic will likely proceed with reimplantation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50322736 ↗
• MalfunctionJul 14, 2026Impedance Problem

  THE USER REPORTED DECLINE IN AUDITORY PERFORMANCE, EVEN WITH NEW AUDIO PROCESSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25809585 ↗
• MalfunctionJul 7, 2026Migration

  THE USER REPORTED DISCOMFORT IN HER RIGHT EAR CANAL, INCLUDING ITCHING, PRURITUS, AND PAIN. AN OTOSCOPY REVEALED THE ELECTRODE ARRAY IN THE MIDDLE EAR, TOUCHING THE TYMPANIC MEMBRANE. EXPLANTATION IS PLANNED WITHOUT REQUESTING A NEW COCHLEAR IMPLANT.

  Patient problems: Ear Pain

  MAUDE report 25730361 ↗
• MalfunctionJun 24, 2026Impedance Problem

  THE USER EXPERIENCED SUDDEN HEARING LOSS. RE-IMPLANTATION WAS DONE ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25604702 ↗
• MalfunctionJun 8, 2026Impedance Problem

  INTERMITTENT SOUNDS WITH CI IN LATE (B)(6) 2026. AP REPLACEMENT, PRESSURE BANDAGING TRIED - NO IMPROVEMENT. RE-IMPLANTATION WAS DONE ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427640 ↗
• MalfunctionMay 21, 2026Impedance Problem

  THE PATIENT'S MOTHER REPORTS THAT SINCE THE MONTH OF DECEMBER, THE PATIENT HAS EXPERIENCED FLUCTUATING HEARING. ON SOME OCCASIONS, SOUNDS ARE PERCEIVED AS MORE UNCOMFORTABLE THAN USUAL, WHILE ON OTHER DAYS THEY ARE REPORTED AS COMFORTABLE. SHE ALSO MENTIONS EPISODES IN WHICH THE PATIENT DOES NOT SEEM TO HEAR ADEQUATELY; HOWEVER, THIS SITUATION IMPROVES SPONTANEOUSLY WITHOUT ANY CHANGES BEING MADE TO THE PROGRAMMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240841 ↗
• MalfunctionMay 20, 2026Lack of Effect

  DURING IMPLANTATION SURGERY, INSERTION RESISTANCE WAS ENCOUNTERED LIKELY DUE TO COCHLEAR OSSIFICATION. THE USER DIDN'T GET BENEFITS FROM THE CI POST-OPERATIVELY, AND ABANDONED WEARING THE EXTERNAL DEVICE. NO POST IMAGING WAS DONE. COCHLEAR NERVE WAS ASSESSED TO BE FUNCTIONING.

  Patient problems: Extraskeletal ossification

  MAUDE report 25226317 ↗
• MalfunctionMay 18, 2026Impedance Problem

  THE USER EXPERIENCED SUDDEN HEARING LOSS WITH THE LEFT CI IN EARLY APR-2026. A HISTORY OF TRAUMA WAS DENIED. NO SWELLING OR REDNESS WAS SEEN. AFTER ONE MONTH OF OBSERVATION WITH NO IMPROVEMENT IN HEARING PERFORMANCE, RE-IMPLANTATION WAS PERFORMED ON (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199772 ↗
• MalfunctionMay 13, 2026Circuit Failure

  THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: Head Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157476 ↗
• MalfunctionApr 24, 2026Impedance Problem

  THE DEVICE WAS EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978586 ↗
• MalfunctionApr 13, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: Head Injury

  MAUDE report 24857589 ↗
• MalfunctionApr 9, 2026Migration

  USER'S HEARING HAS BEEN DETERIORATING IN THE PAST YEAR. ON (B)(6) 2026, PATIENT WAS SEEN BY ENT AND ELECTRODE ARRAY WAS FULLY OUT OF THE COCHLEA. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831581 ↗
• MalfunctionApr 2, 2026Impedance Problem

  THE USER_S HEARING PERFORMANCE WITH THE DEVICE IS REDUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762504 ↗
• MalfunctionMar 5, 2026Impedance Problem

  THE USER'S PARENT REPORTED HEARING LOSS FOLLOWING A HEAD IMPACT ON (B)(6) 2026. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 24518993 ↗
• MalfunctionJan 28, 2026Impedance Problem

  HEARING PERFORMANCE HAS DETERIORATED. THE USER CAN FEEL SOME BULGE IN HIS IMPLANTED SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200670 ↗
• InjuryJan 22, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  On (b)(6)2026, the left implant was removed for further treatment of a skin flap infection.

  Patient problems: Bacterial Infection

  MAUDE report 24143397 ↗
• MalfunctionJan 14, 2026Impedance Problem

  THE USER BUMPED HIS HEAD ON THE TABLE EDGE IN (B)(6) 2025, RESULTING IN SWELLING AND REDNESS OVER THE IMPLANT. HOWEVER, AFTER THE SWELLING SUBSIDED, HE WAS UNABLE TO HEAR SOUNDS WITH THE CI. THE USER WAS RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 24065676 ↗
• MalfunctionJan 7, 2026Impedance Problem

  AFTER ABOUT TWO YEARS OF OBSERVATION, THERE WAS NO IMPROVEMENT IN HEARING PERFORMANCE. THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23990291 ↗
• MalfunctionDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANT RETURNED TO HQ FOR INVESTIGATION WITH MENTION OF PAIN, TINNITUS AND NON-USER SINCE 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919980 ↗
• InjuryDec 16, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  LAST MONTH, THE USER EXPERIENCED A SKIN INFECTION AND ELECTRODE EXTRUSION IN THE EAR CANAL. INFECTION HAD SPREAD TO THE IMPLANT. THE USER WAS EXPLANTED. AT EXPLANTATION IT WAS FOUND THAT THE COIL HAD EXTRUDED THROUGH THE SKIN AND THE DEVICE HAD MIGRATED POSTERIORLY.

  Patient problems: Tissue Breakdown

  MAUDE report 23815863 ↗
• MalfunctionDec 10, 2025Impedance Problem; Impedance Problem

  THE USER SUFFERED FROM A HEAD IMPACT. HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS BEEN REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23765970 ↗
• MalfunctionNov 27, 2025Impedance Problem; Impedance Problem

  THE PARENT REPORTED A SUDDEN HEARING DECLINE WITH THE RIGHT COCHLEA IMPLANT DUE TO A POSSIBLE HEAD IMPACT. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 23663567 ↗

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-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