RONDO 3 Me1550 (DIAMETRAL) black 39908Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 09008737399085), received between Feb 17, 2022 and Jan 23, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Fluid/Blood Leak

  DURING THE DEVICE INVESTIGATION IN SERVICE AND REPAIR A LEAKING BATTERY WAS FOUND AND THE DEVICE HOUSING IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158979 ↗
• MalfunctionOct 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS SENT TO SERVICE REPAIR DUE TO BEING NON-FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321343 ↗
• MalfunctionJan 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE _ REPAIR. UPON FIRST INVESTIGATION, THE RONDO 2 HAD A BROKEN HOUSING AND A AND LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099844 ↗
• MalfunctionOct 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE WAS RECEIVED AT SERVICE_REPAIR ON 13-AUG-2024. BASED ON THE RRF IT WAS SENT FOR REPAIR DUE TO OPTICAL DAMAGE. UPON FIRST INVESTIGATION, A BROKEN HOUSING AND A LEAKING BATTERY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20393252 ↗
• MalfunctionJun 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A RONDO 2 AUDIO PROCESSOR WITH A LEAKING BATTERY AND A BROKEN WELDING SEAM WAS RECEIVED AT HQ. THE DEVICE WAS SENT BACK DUE TO THE BROKEN WELDING SEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19565383 ↗
• MalfunctionMar 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT HQ WITH A DAMAGED HOUSING. IT WAS NOTED THAT THIS IS A RECURRING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18835231 ↗
• MalfunctionJan 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 3 AUDIO PROCESSOR ARRIVED AT HQ WITH A DAMAGED HOUSING, INHIBITING THE DEVICE'S MAGNET REMOVAL, AND IT WAS FOUND TO HAVE A LEAKING BATTERY. THE DEVICE WAS NOT FOUND TO BE LEAKING BEFORE IT WAS SENT BACK TO HQ. THE USER WAS NOT HARMED DUE TO THE LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569227 ↗
• MalfunctionNov 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 3 AUDIO PROCESSOR WAS RECEIVED BY SERVICE AND REPAIR WHERE UPON PRELIMINARY INVESTIGATION A DAMAGED HOUSING AND LEAKING BATTERY WAS NOTED. TO DATE NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109274 ↗
• MalfunctionJul 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE _ REPAIR ON (B)(6) 2023. THE DEVICE WAS REPORTED TO BE NON-FUNCTIONAL BECAUSE OF A DAMAGED HOUSING AND A LEAKING BATTERY.

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

  MAUDE report 17276616 ↗
• MalfunctionFeb 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT HQ. DURING A NORMAL SERVICE REPAIR, A LEAKING RONDO 3 BATTERY WAS DISCOVERED. ACCORDING TO THE RRF, THE AUDIO PROCESSOR WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13548693 ↗

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
• 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. Mi100
• 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