SONATATI100 +FLEXsoft 04917Recalls & reported problems

Summary

The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 09008737049171), received between Jul 9, 2018 and May 18, 2026 — classified as 53 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Output Problem” (117 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 182 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Impedance Problem

  THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: Head Injury

  MAUDE report 25197785 ↗
• MalfunctionApr 9, 2026Impedance Problem

  THE RECIPIENT DOES NOT RESPOND PROPERLY WITH THE DEVICE IN THE LAST THREE MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24825839 ↗
• MalfunctionApr 7, 2026Impedance Problem

  THE DEVICE WAS EXPLANTED.

  Patient problems: Head Injury

  MAUDE report 24797383 ↗
• MalfunctionMar 26, 2026Impedance Problem

  THE USER HAS NOT BEEN RESPONDING TO SOUNDS FOR THE PAST 4 MONTHS. THE PARENT ALSO REPORTED THAT THE CHILD HAD A FALL AND A POSSIBLE HEAD BANG ON THE IMPLANT SIDE 4 MONTHS AGO, FOLLOWING WHICH THE ISSUE WAS NOTICED.

  Patient problems: Head Injury

  MAUDE report 24697971 ↗
• MalfunctionFeb 3, 2026Impedance Problem

  THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24243988 ↗
• MalfunctionJan 2, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23941684 ↗
• MalfunctionDec 16, 2025Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816500 ↗
• MalfunctionDec 5, 2025Impedance Problem; Impedance Problem

  THE AUDIOLOGIST REPORTED THE USER HAD A RECENT FALL ON THE IMPLANTED RIGHT SIDE AND POOR PERFORMANCE FOLLOWED.

  Patient problems: Head Injury

  MAUDE report 23725190 ↗
• MalfunctionSep 9, 2025Impedance Problem; Impedance Problem

  A DECLINE IN HEARING PERFORMANCE OF THE USER WAS OBSERVED RECENTLY. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004825 ↗
• MalfunctionJun 24, 2025Impedance Problem; Impedance Problem

  PARENT BROUGHT THE CHILD TO THE CLINIC REPORTING NOT RESPONDING TO SOUNDS WITH THE DEVICE FOR THE PAST 2 MONTHS. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313556 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE RECIPIENT NEVER HAD EXPERIENCED HEARING BENEFIT FROM THE DEVICE. DEMONSTRATING ONLY SOUND DETECTION FOR LOUD IMPACT NOISES; HOWEVER, THIS INFORMATION WAS NEVER COMMUNICATED TO THE MED-EL CLINICAL SUPPORT TEAM. IN RECENT YEARS, THE RECIPIENT HAD DISCONTINUED FOLLOW-UP APPOINTMENTS. HE DEVELOPED A SIGNIFICANT MIDDLE EAR INFECTION, AND THE FAMILY DECIDED TO PROCEED WITH EXPLANTATION. THE RECIPIENT HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22156777 ↗
• MalfunctionMay 20, 2025Impedance Problem; Impedance Problem

  PARENT BROUGHT THE CHILD TO THE CLINIC REPORTING THAT THE RECIPIENT WAS NOT RESPONDING TO SOUNDS WITH THE DEVICE FOR THE PAST 1 MONTH. RE-IMPLANTATION IS CONSIDERED. IMAGING WILL FOLLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22055023 ↗
• MalfunctionMay 20, 2025Impedance Problem; Impedance Problem

  PARENT BROUGHT THE CHILD TO THE CLINIC REPORTING THAT THE RECIPIENT WAS NOT RESPONDING TO SOUNDS FOR THE PAST 3 WEEKS WITH THE DEVICE DUE TO A TRAUMA. PARENTS NOTICED HEARING ISSUES WITH THE DEVICE AFTER THIS INCIDENT. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 22055020 ↗
• MalfunctionApr 28, 2025Impedance Problem; Impedance Problem

  THE PARENT REPORTED THAT THE CHILD WAS NOT RESPONDING TO SOUNDS WITH THE DEVICE FOR THE PAST 1 MONTH. HE GOT HIT ON THE IMPLANT SIDE MULTIPLE TIMES. HOWEVER, THE RECIPIENT WAS NOT USING THE EXTERNAL DEVICE FOR ALMOST 1 YEAR. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Head Injury

  MAUDE report 21916364 ↗
• MalfunctionMar 13, 2025Impedance Problem; Impedance Problem

  PARENT BROUGHT THE CHILD TO THE CLINIC REPORTING NOT RESPONDING SOUNDS FOR THE PAST 1 WEEK WITH THE DEVICE. SHE FELL AND GOT HIT ON THE IMPLANT SIDE, PARENTS NOTICED HEARING ISSUES AFTER THIS INCIDENT. THE CLINIC IS PLANNING FOR RE-IMPLANTATION. RECOMMENDED TO TAKE AN X-RAY.

  Patient problems: Failure of Implant

  MAUDE report 21591612 ↗
• MalfunctionJan 13, 2025Impedance Problem; Impedance Problem

  CHILD CAME TO HOSPITAL FOR REVIEW MAPPING ON (B)(6) 2025, WHERE AFFECTED CHANNELS WERE SEEN. ON FURTHER ENQUIRY PARENTS INFORMED THAT CHILD WAS NOT RESPONDING TO SOUNDS FOR 2 MONTHS. FURTHER PROCEEDINGS ARE UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 21137326 ↗
• MalfunctionJan 8, 2025Impedance Problem; Impedance Problem

  THE RECIPIENT WAS ACCOMPANIED WITH PARENT ON (B)(6) 24 REPORTING SWELLING ON THE IMPLANT SITE AND MENTIONING A HISTORY OF FALL, HOWEVER, THE EVENT INFORMATION WAS NOT DETAILED. AFTER THE SWELLING WAS SETTLED, THE CHILD WAS MENTIONING THAT THE AUDITORY PERCEPTION WAS AFFECTED. FURTHER TECHNICAL CHECKS ARE CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 21099222 ↗
• MalfunctionDec 9, 2024Impedance Problem; Impedance Problem

  PARENT BROUGHT THE CHILD TO THE CLINIC REPORTING NOT RESPONDING TO SOUNDS WITH THE DEVICE. THE RECIPIENT HAS BEEN RE-IMPLANTED.

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

  MAUDE report 20877778 ↗
• MalfunctionNov 15, 2024Impedance Problem; Impedance Problem

  REPORTEDLY, THE USER CAN ONLY HEAR PROPERLY WHEN HE IS PUSHING ON THE IMPLANT SIDE. THE FIELD SUSPECTS AIR AROUND THE IMPLANT BODY. PER NEW INFORMATION RECEIVED ON 19-NOV-2024, THE USER HEARS FINE AS BEFORE. POSITIONING OF THE COIL IS NORMAL AND THERE IS NO NEED TO APPLY PRESSURE ANYMORE TO HEAR. THE USER IS SATISFIED WITH THE CURRENT HEARING AND DOES NOT WANT ANY FURTHER CHANGES, AND CERTAINLY NOT ANY KIND OF INTERVENTION.

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

  MAUDE report 20692872 ↗
• MalfunctionOct 17, 2024Impedance Problem; Impedance Problem

  THE RECIPIENT CAME WITH HIS FAMILY TO OUR DISTRIBUTOR SINCE HE REPORTED THAT HIS HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED IN THE RIGHT EAR. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 20469418 ↗
• MalfunctionSep 18, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IT WAS REPORTED THAT THE CHILD WAS NO LONGER PROPERLY RESPONDING TO SOUNDS WHEN USING THE DEVICE. RE-IMPLANTATION IS BEING CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 20244519 ↗
• MalfunctionSep 3, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE PARENTS REPORTED THAT THE USER WAS UNABLE TO HEAR SOUNDS WITH THE DEVICE ON (B)(6) 2024. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20124959 ↗
• MalfunctionAug 27, 2024Impedance Problem; Impedance Problem

  THE PARENT REPORTED THAT THE RECIPIENT HAD A HEAD TRAUMA NEAR THE IMPLANT IN EARLY (B)(6) 2024 WITH RESULT IN THE LOSS OF HEARING WITH DEVICE. SWELLING AND REDNESS WAS SEEN. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20073813 ↗
• MalfunctionAug 27, 2024Migration; Migration

  THE PARENT REPORTED THAT THE RECIPIENT DID NOT HAVE A GOOD BENEFIT FROM THE DEVICE AFTER IMPLANTATION IN 2014, HOWEVER, THIS WAS NOT EARLIER REPORTED. AS THE HEARING BENEFIT WITH THE DEVICE GOT EVEN WORSE THIS YEAR, THE RECIPIENT WITH HIS PARENT WENT TO THE HOSPITAL FOR FURTHER EXAMINATION IN EARLY (B)(6) 2024. THE RECIPIENT HAS BEEN RE-IMPLANTED WITH A COMPRESSED ARRAY.

  Patient problems: Failure of Implant

  MAUDE report 20073558 ↗
• InjuryJul 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT WAS IMPLANTED IN 2022, HOWEVER, DUE TO REPEATED INFECTIONS ON TOP OF THE RECEIVED, THE RECIPIENT WAS NOT ABLE TO WEAR THE AUDIO PROCESSOR. THEREFORE, DECISION TO EXPLANT THE DEVICE WAS MADE. HEARING PERFORMANCE ALSO DEGRADED AS THE CHILD WAS NOT ABLE TO USE THE AUDIO PROCESSOR. FURTHERMORE, THE RECIPIENT WAS TREATED WITH IV ANTIBIOTICS AND DAILY WOUND SITE DRESSING. HOWEVER, FOR TYPE OF INFECTION IT WAS MENTIONED BY SURGEON AS BACTERIAL BIOFILM FORMATION. THE RECIPIENT HAS BEEN EXPLANTED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 19727711 ↗

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-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