FineTuner Echo & Battery 37342Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 09008737373429), received between Aug 5, 2021 and Dec 24, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Circuit Failure” (13 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Circuit Failure; Circuit Failure

  DURING DEVICE INVESTIGATION A FAILED CAPACITOR WAS DETECTED WHICH WAS CLEARLY THE REASON FOR MALFUNCTIONING. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886582 ↗
• MalfunctionDec 24, 2024Circuit Failure; Circuit Failure

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. UPON PRELIMINARY INVESTIGATION AT SERVICE AND REPAIR IT WAS DETERMINED THAT THERE IS FAILURE OF THE TANTALUM CAPACITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21009795 ↗
• MalfunctionNov 22, 2023Circuit Failure; Circuit Failure

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191671 ↗
• MalfunctionOct 6, 2023Circuit Failure; Circuit Failure

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. ACCORDING TO THE REPAIR REQUEST FORM, THE DEVICE HAD NO FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17884361 ↗
• MalfunctionSep 13, 2023Circuit Failure; Circuit Failure

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. ACCORDING TO THE REPAIR REQUEST FORM, THE DEVICE HAD NO FUNCTION. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17734903 ↗
• MalfunctionSep 13, 2023Circuit Failure; Circuit Failure

  ACCORDING TO THE REPAIR REQUEST FORM, THE DEVICE HAD NO FUNCTION. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17734897 ↗
• MalfunctionAug 17, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. THE DEVICE WAS RETURNED DUE TO DEFECT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17563412 ↗
• MalfunctionAug 10, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. ACCORDING TO THE REPAIR REQUEST FORM, THE DEVICE HAD NO FUNCTION. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17498434 ↗
• MalfunctionJul 31, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. UPON PRELIMINARY INVESTIGATION AT SERVICE AND REPAIR IT WAS DETERMINED THERE IS FAILURE OF THE TANTALUM CAPACITOR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424134 ↗
• MalfunctionJul 27, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR FOR UNKNOWN REASON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17403665 ↗
• MalfunctionJul 12, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR BECAUSE OF BEING DEFECTIVE. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304599 ↗
• MalfunctionJul 11, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR BECAUSE OF NO FUNCTION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17298475 ↗
• MalfunctionJul 10, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. THE DEVICE WAS RETURNED BECAUSE THE RECIPIENT COULD NOT LONGER USE THE REMOTE CONTROL. IT SEEMED TO HAVE DEFORMED AND IT RATTLED INSIDE THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286677 ↗
• MalfunctionJul 10, 2023No Device Output; Mechanics Altered; No Device Output; Mechanics Altered

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. FINETUNER ECHO CAN NO LONGER BE UNLOCKED DESPITE NEW BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286676 ↗
• MalfunctionJul 10, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. THE DEVICE WAS RETURNED DUE TO DEFECT. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286519 ↗
• MalfunctionMay 11, 2023Overheating of Device; Overheating of Device

  THE FINE TUNER ECHO SHOWS A BULGING BUBBLE ON ITS BACKSIDE. THE BULGE IS LOCATED ON THE QR-CODE/SERIAL NUMBER, BETWEEN THE BATTERY AND THE LOWER END OF THE FINETUNER ECHO. THERE WAS NO REPORT OF THE DEVICE HEATING UP. THE DEVICE HAS BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911596 ↗
• MalfunctionJan 20, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. THE USER SENT THE DEVICE IN FOR SERVICE BECAUSE IT WAS NO LONGER FUNCTIONAL. REPORTEDLY RESETTING THE DEVICE AS WELL AS REPLACING THE BATTERY DID NOT WORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213338 ↗
• MalfunctionDec 30, 2022No Device Output; Output Problem; No Device Output; Output Problem

  THE FINETUNER ECHO WAS RECEIVED AT SERVICE AND REPAIR AND THE REPAIR REQUEST FORM (RRF) STATED THAT THERE WAS A MECHANICAL PROBLEM. THE USER REPORTED THAT IT WAS DIFFICULT TO REMOVE THE BATTERY AND THE SCREEN WAS BLOCKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16076657 ↗
• MalfunctionDec 16, 2022No Device Output; Output Problem; No Device Output; Output Problem

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR AS REPORTEDLY IT WOULD NO LONGER REACT AND LOW BATTERY WARNING. WHEN NEW BATTERIES WERE TRIED IT SHOWED THAT THEY WERE EMPTY AND WOULD NOT REACT TO ANY BUTTON. THE DEVICE COULD ALSO NOT BE RESET BY PRESSING THE BUTTONS 3 TIMES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15994174 ↗
• MalfunctionOct 31, 2022Output Problem; Output Problem

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698682 ↗
• MalfunctionOct 5, 2022Output Problem; Output Problem

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. UPON PRELIMINARY INVESTIGATION AT SERVICE AND REPAIR IT WAS DETERMINED THERE IS FAILURE OF THE TANTALUM CAPACITOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543365 ↗
• MalfunctionOct 5, 2022Output Problem; Output Problem

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. ACCORDING TO THE REPAIR REQUEST FORM THERE WAS NO OUTPUT OR SIGNAL. UPON PRELIMINARY INVESTIGATION AT SERVICE AND REPAIR IT WAS DETERMINED THERE IS FAILURE OF THE TANTALUM CAPACITOR.

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

  MAUDE report 15543159 ↗
• MalfunctionJul 18, 2022Output Problem; Output Problem

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15041523 ↗
• MalfunctionSep 7, 2021Output Problem; Output Problem

  THE FINE TUNER ECHO WAS RETURNED TO SERVICE AND REPAIR DUE TO NO FUNCTION I.E. IT COULD NOT BE SYNCHRONIZED WITH THE AUDIO PROCESSOR. NO INJURY HAS BEEN REPORTED; THE MALFUNCTION WAS IDENTIFIED DURING THE FIRST FITTING AND THE DEVICE WAS NEVER GIVEN TO ANY USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12431774 ↗
• MalfunctionAug 5, 2021Output Problem; Output Problem

  THE FINE TUNER ECHO BATTERY WERE RETURNED TO SERVICE AND REPAIR. ACCORDING TO THE REPAIR REQUEST FORM, THERE WAS NO OUTPUT AND NO SIGNAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12279169 ↗

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