FineTuner Echo 34429Recalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 09008737344290), received between Feb 23, 2021 and Nov 21, 2025 — classified as 105 malfunctions.

The most frequently reported specific device problem is “Output Problem” (76 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 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Circuit Failure; Circuit Failure

  DURING ANALYZING THE DEVICE IN SERVICE _ REPAIR, A BURNED TANTALUM CAPACITOR WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614492 ↗
• MalfunctionMar 13, 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. 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 18892159 ↗
• MalfunctionFeb 21, 2024Circuit Failure; Circuit Failure

  A FINE TUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. ACCORDING TO THE REPAIR REQUEST FORM, THE DEVICE HAD BATTERY PROBLEMS. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18745777 ↗
• MalfunctionFeb 2, 2024Circuit Failure; Circuit Failure

  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. ACCORDING TO THE REPAIR REQUEST FORM, THE DEVICE WAS REPORTED TO BE NON-FUNCTIONAL. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18629881 ↗
• MalfunctionJan 19, 2024Circuit Failure; Circuit Failure

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. ACCORDING TO THE REPAIR REQUEST FORM, THE DEVICE WAS REPORTED TO BE NON-FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541029 ↗
• MalfunctionJan 17, 2024Circuit Failure; Circuit Failure

  A FINE TUNER ECHO WITH A BURNED TANTALUM CAPACITOR WAS RECEIVED AT SERVICE_REPAIR ON (B)(6) 2023. ACCORDING TO THE RRF, THE DEVICE WAS NON-FUNCTIONAL. THE REPLACEMENT OF THE DEVICE WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18525496 ↗
• MalfunctionOct 4, 2023Circuit Failure; Circuit Failure

  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.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 17866319 ↗
• MalfunctionSep 5, 2023Circuit Failure; Circuit Failure

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17680842 ↗
• MalfunctionMay 19, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. THE DEVICE WAS RETURNED DUE TO DEFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16960275 ↗
• MalfunctionMay 15, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR DUE TO MECHANICAL PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929643 ↗
• MalfunctionMay 15, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929640 ↗
• MalfunctionApr 7, 2023No Device Output; 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. THE STATED REASON FOR RETURN TO SERVICE AND REPAIR WAS DUE TO NON-FUNCTION. TO DATE, NO INJURIES HAVE BEEN REPORTED.

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

  MAUDE report 16699475 ↗
• MalfunctionApr 7, 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. THE STATED REASON FOR RETURN TO SERVICE AND REPAIR WAS DUE TO NON-FUNCTION. TO DATE, NO INJURIES HAVE BEEN REPORTED.

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

  MAUDE report 16699472 ↗
• MalfunctionApr 7, 2023No Device Output; 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. TO DATE, NO INJURIES HAVE BEEN REPORTED.

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

  MAUDE report 16699471 ↗
• MalfunctionMar 29, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR DUE TO A DEFECT.

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

  MAUDE report 16633665 ↗
• MalfunctionMar 24, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR AS ACCORDING TO THE REPAIR REQUEST FORM THERE WAS NO FUNCTION AS THE SCREEN WAS FROZEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16608557 ↗
• MalfunctionMar 13, 2023No Device Output; No Device Output

  ON 5TH MARCH 2023 THE EXTERNAL DEVICE STARTED TO SMELL BURNT AND THE USER'S MOTHER GOT A SMALL ELECTRIC SHOCK. THERE WAS NO SERIOUS INJURY SUSTAINED FROM THE BRIEF SHOCK.

  Patient problems: Burning Sensation

  MAUDE report 16528150 ↗
• MalfunctionMar 7, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR DUE INTERMITTENT FUNCTION.

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

  MAUDE report 16495852 ↗
• MalfunctionFeb 20, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR DUE TO A DEFECT WHICH OCCURRED IN (B)(6) 2022. THE DEVICE WAS REPLACED IN (B)(6) 2022.

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

  MAUDE report 16403055 ↗
• MalfunctionFeb 15, 2023No Device Output; No Device Output

  THE FINETUNER ECHO WAS RECEIVED AT SERVICE AND REPAIR AND THE REPAIR REQUEST FORM (RRF) STATED THAT THERE WAS INTERMITTENT FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377664 ↗
• MalfunctionFeb 14, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RECEIVED AT SERVICE AND REPAIR ALONG WITH THE REPAIR REQUEST FORM (RRF) WHICH STATED THAT THE DEVICE WAS NOT FUNCTIONING.

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

  MAUDE report 16370443 ↗
• MalfunctionFeb 14, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RECEIVED AT SERVICE AND REPAIR ALONG WITH THE REPAIR REQUEST FORM (RRF) WHICH STATED THAT THE DEVICE WAS NOT FUNCTIONING.

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

  MAUDE report 16370379 ↗
• MalfunctionFeb 7, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR STATING IT WAS DEFECTIVE AND THERE WAS MELTING OF THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16309863 ↗
• MalfunctionJan 26, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RECEIVED AT SERVICE AND REPAIR ALONG WITH THE REPAIR REQUEST FORM (RRF). THE PROBLEM WAS THOUGHT TO BE THE BATTERY, IT LOST CHARGE FREQUENTLY AND THE USER HAD TO CHANGE IT ALMOST EVERY TIME HE USES IT. TOO MANY BATTERIES FOR FEW USES. REPORTEDLY, THE DEVICES DID NOT RECEIVE ANY MISHANDLING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16246740 ↗
• MalfunctionJan 20, 2023No Device Output; No Device Output

  A FINETUNER ECHO WAS RETURNED TO SERVICE AND REPAIR. THE USER REPORTED THAT THE DEVICE WOULD NOT PAIR TO THE PROCESSOR. RESETTING THE DEVICE WAS NOT POSSIBLE BECAUSE THE BATTERY COVER COULD NOT BE REMOVED DUE TO BEING STRIPPED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213336 ↗

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-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