AudioLink Main Unit 37028Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09008737370282), received between Nov 7, 2021 and May 8, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A TOTALLY DESTROYED RONDO 3 DEVICE WITH AN OPENED DEVICE AND RECHARGEABLE BATTERY HOUSING WAS RECEIVED AT HQ. THE USER REPORTED THAT ONE DAY THE AUDIO PROCESSOR FELL OFF, THE USER DID NOT SUFFER ANY HARM OR ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE.

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

  MAUDE report 16884324 ↗
• MalfunctionNov 11, 2021Output Problem; Output Problem

  AN AUDIOLINK MAIN UNIT INCLUDING BATTERY WAS RETURNED WITH A BURNED USB PORT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12795850 ↗
• MalfunctionNov 7, 2021Output Problem; Output Problem

  THE AUDIOLINK MAIN UNIT RECENTLY RECEIVED HAS A BURNED USB PORT WHICH WAS DISCOVERED AT SERVICE AND REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12757979 ↗
• MalfunctionNov 7, 2021Output Problem; Output Problem

  AUDIOLINK MAIN UNIT INCLUDING BATTERY AND DOCKING STATION WE RECENTLY RECEIVED WHICH HAVE A BURNED USB PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12757881 ↗

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-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