SONATATI100 +FLEX24 04918Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 09008737049188), received between Aug 8, 2019 and Sep 25, 2026 — classified as 9 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Output Problem” (14 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 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Impedance Problem

  In situ measurements from (b)(6) 2023, there was an identified abnormal impedance across 5 channels following a bump. However, no marked deterioration in hearing performance was observed at that time. Three years later, the number of channels with abnormal impedance rose to seven.The user has been re-implanted.

  Patient problems: Head Injury

  MAUDE report 50894912 ↗
• MalfunctionMay 29, 2026Impedance Problem

  THE USER HAS NOT USED THE DEVICE FOR 6 YEARS AFTER LOSING THE AP. HE WAS UNABLE TO AFFORD A REPLACEMENT. VIA PUBLIC FUNDING HE WOULD BE ABLE TO GET A NEW PROCESSOR. NEXT STEPS INCLUDE PERFORMING INTEGRITY TEST _ AWAITING INTERNAL DEVICE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25328688 ↗
• MalfunctionMay 7, 2026Impedance Problem

  THE DEVICE WAS EXPLANTED.

  Patient problems: Head Injury

  MAUDE report 25112056 ↗
• MalfunctionJun 24, 2025Impedance Problem; Impedance Problem

  THE RECIPIENT HAS NOT BEEN USING THE AUDIO PROCESSOR FOR 2 YEARS DUE TO MAINTENANCE DIFFICULTIES. ON THE DAY OF UPGRADE ACTIVATION, AFFECTED CHANNELS WERE SEEN DURING TESTING. FURTHER PROCEEDINGS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313553 ↗
• MalfunctionSep 19, 2024Migration; Migration

  ON (B)(6) 2024 THE RECIPIENT REPORTED EXPERIENCING A HEADACHE. THE FOLLOWING DAY THE RECIPIENT WENT TO THE HOSPITAL FOR EXAMINATION. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Headache

  MAUDE report 20253220 ↗
• MalfunctionJul 11, 2024Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE RECIPIENT WAS IMPLANTED AS SINGLE SIDED DEAFNESS (SSD) SINCE A COUPLE OF YEARS DUE TO OSSIFYING LABYRINTHITIS. DUE TO SEVERE OSSIFICATION, ONLY 3 CHANNELS WERE FUNCTIONAL. REPORTEDLY, SOME CHANNELS WERE EXTRA-COCHLEAR AND OTHERS CAUSE SEVERE FACIAL NERVE STIMULATION. THE RECIPIENT HAD A REVISION SURGERY ON (B)(6) 2021 DUE TO THE EXTRA-COCHLEAR CHANNELS, HOWEVER, WITHOUT ANY IMPROVEMENT. THE RECIPIENT VISITED ANOTHER CLINIC FOR EXPLANTATION.

  Patient problems: Extraskeletal ossification; Undesired Nerve Stimulation

  MAUDE report 19717482 ↗
• MalfunctionMay 19, 2023Impedance Problem; Impedance Problem

  SINCE (B)(6) 2023, THE USER WAS COMPLAINING ABOUT DECREASED HEARING PERFORMANCE WITH THE DEVICE. RE-IMPLANTATION IS CONSIDERED BUT HAS NOT BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 16960282 ↗
• MalfunctionMay 8, 2023Impedance Problem; Impedance Problem

  DURING A FITTING APPOINTMENT ON 06-AUG-2021 IT WAS OBSERVED THAT SOME CHANNELS HAD FLUCTUATING IMPEDANCES BUT THE USER DID NOT REPORT ANY PROBLEM WITH THE HEARING PERFORMANCE WHEN USING THE DEVICE. THE USER_S PARENT REPORTED THAT ON 13-AUG-2022, THE USER COULD NOT HEAR NORMALLY WITH THE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16885198 ↗
• MalfunctionApr 13, 2023Impedance Problem; Impedance Problem

  THE PARENTS REPORTED THAT THE RECIPIENT HAD A BLOW TO HER HEAD ON 01-MAR-2023. AFTER THE ACCIDENT, THE RECIPIENT_S HEARING PERFORMANCE WITH THE DEVICE WAS NOT GOOD.THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16730178 ↗
• MalfunctionFeb 15, 2023Circuit Failure; Circuit Failure

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. REPORTEDLY, THE SURGEON HAS RECOMMENDED TO RE-IMPLANT THE RECIPIENT DUE TO THE COMPLETE LOSS OF CONNECTION BETWEEN THE IMPLANT AND EXTERNAL DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 16377183 ↗
• MalfunctionJan 4, 2023Impedance Problem; Impedance Problem

  THE PARENTS REPORTED THAT THE USER HAD A HEAD TRAUMA WITH BLEEDING IN THE (B)(6) 2022, AFTERWARDS HE SHOWED POOR AUDITORY RESPONSES WITH THE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16094415 ↗
• MalfunctionDec 15, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER HEARING PERFORMANCE WITH THE DEVICE WAS LIMITED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15985754 ↗
• MalfunctionAug 30, 2022Output Problem; Output Problem

  THE USER HAS STOPPED HEARING WITH THE DEVICE AFTER A HEAD TRAUMA OCCURRED ON (B)(6) 2022 AND CHANNELS WITH ABNORMAL IMPEDANCES WERE FOUND. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15318501 ↗
• MalfunctionMar 18, 2022Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AND CHANNELS WITH ABNORMAL IMPEDANCES WERE FOUND.

  Patient problems: Failure of Implant

  MAUDE report 13804077 ↗
• MalfunctionFeb 21, 2022Output Problem; Output Problem

  THE USER BUMPED HIS HEAD ON (B)(6) 2022 AND THEN COULD NO LONGER HEAR WITH THE DEVICE. THE USER WAS RE-IMPLANTED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 13567295 ↗
• MalfunctionFeb 21, 2022Output Problem; Output Problem

  THE USER ATTENDED FOR A FIRST REVIEW MAPPING APPOINTMENT IN (B)(6), AFTER RELOCATING FROM (B)(6) AND CHANNELS WITH ABNORMAL IMPEDANCES WERE FOUND.

  Patient problems: Failure of Implant

  MAUDE report 13567253 ↗
• MalfunctionJan 3, 2022Output Problem; Output Problem

  THE USER HAD ABNORMAL IMPEDANCE LEVELS AND POOR HEARING PERFORMANCE WITH THE DEVICE DURING A APPOINTMENT IN (B)(6) 2021. THE USER WAS RE-IMPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 13142032 ↗
• InjuryAug 19, 2021Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE HAS BEEN DECREASING OVER THE PAST MONTHS AND SHE HAS NO ACCESS TO SOUND NOW. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12341047 ↗
• MalfunctionAug 2, 2021Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER WAS SEEN ON (B)(6) 2021 FOR HIS ANNUAL FITTING. IN SITU TESTING DONE DURING THIS APPOINTMENT SHOWED ALL CHANNELS AFFECTED WITH HIGH IMPEDANCE OR SHORT CIRCUITS. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12257703 ↗
• InjuryJun 14, 2021Output Problem; Output Problem

  THE USER'S GUARDIANS NOTED A SIGNIFICANT LOSS OF HEARING WITH THE DEVICE AFTER A TRAUMA TO THE HEAD. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11991454 ↗
• InjuryFeb 10, 2021Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS. THE USER WAS RE-IMPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11307670 ↗
• InjuryDec 29, 2020Output Problem; Output Problem

  WHEN THE USER CAME FOR A REGULAR CHECK-UP, IN SITU TESTING SHOWED AFFECTED CHANNELS. HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE PARENTS HAD PREVIOUSLY NOT NOTICED ANY CHANGE OF HEARING OR BEHAVIOR AT HOME.

  Patient problems: Failure of Implant

  MAUDE report 11085585 ↗
• InjuryOct 27, 2020Migration; Migration

  SEVERAL MONTHS AFTER IMPLANTATION A MIGRATION OF THE IMPLANT HOUSING DOWN TO THE LEVEL OF THE AUDIO PROCESSOR WAS NOTICED. BECAUSE OF PAIN, THE IMPLANT HOUSING WAS REPOSITIONED ON (B)(6) 2020. AFTER REVISION SURGERY AFFECTED CHANNELS AND EXTRA-COCHLEA CHANNELS WERE OBSERVED. THE RECIPIENT WAS RE-IMPLANTED ON (B)(6) 2020.

  Patient problems: Implant Pain

  MAUDE report 10740469 ↗
• InjuryAug 26, 2020Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration

  WHILE THE USER WAS UNDERGOING AN EAR CLEANING PROCEDURE THE ELECTRODE LEAD WAS FOUND TO BE IN THE EXTERNAL AUDITORY CANAL. REPAIR OF THE EXTERNAL AUDITORY CANAL AND RE-IMPLANTATION HAD BEEN SUGGESTED. THE USER WAS RE-IMPLANTED ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10452678 ↗
• InjuryJun 3, 2020Output Problem; Output Problem

  THE USER'S FATHER REPORTED THAT THE USER FELL ON THE SIDE OF THE IMPLANT AROUND THE MIDDLE OF (B)(6) 2020. THE USER DEVELOPED A HAEMATOMA ON THE EAR. SINCE THEN SHE CAN NO LONGER HEAR WITH THE DEVICE. THE USER'S HEARING PERFORMANCE WITH THE DEVICE BEFORE THE TRAUMA WAS GOOD.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 10113583 ↗

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