RONDO 3 Processor Unit Me1550 black 39246Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 09008737392468), received between Feb 17, 2022 and Sep 16, 2026 — classified as 40 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (34 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787480 ↗
• MalfunctionSep 16, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50787400 ↗
• MalfunctionSep 2, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562720 ↗
• MalfunctionNov 24, 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 23629109 ↗
• MalfunctionSep 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE'S HOUSING IS BROKEN, AND THE BUILT-IN BATTERY IS DAMAGED, LEADING TO LEAKING ELECTROLYTE. THE SILICONE COVER TO PROTECT THE BATTERY IS ALSO DAMAGED DUE TO THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130794 ↗
• MalfunctionSep 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS SENT TO SERVICE _ REPAIR FOR MAINTENANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084359 ↗
• MalfunctionMay 13, 2025Crack; Crack

  THE RONDO 3 AUDIO PROCESSOR WAS RETURNED SEVERELY BROKEN. THERE IS A SUBSTANCE ON THE DEVICE THAT_S LIQUID. RECEIVED IMAGES OF THE DEVICE SHOW AN OXIDIZED MAGNET, AND ALSO A MAGNET COMPARTMENT WITH LIQUID RESIDUES, WHICH CLEARLY COME FROM AN EXTERNAL LIQUID EXPOSURE. IMAGES OF THE BATTERY SHOW SOME SLIGHT OXIDATION OF THE BATTERY CONTACTS, WHICH COULD POTENTIALLY BE FROM A LEAKING BATTERY, HOWEVER, DUE TO THE SEVERELY DAMAGED DEVICE STATUS IT COULD ALSO BE DUE TO EXTERNAL LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22008764 ↗
• MalfunctionApr 28, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE RONDO 3 WAR RECEIVED AT S_R AND A CRACKED HOUSING WAS FOUND AS WELL AS A LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916367 ↗
• MalfunctionApr 28, 2025Crack; No Device Output; Crack; No Device Output

  THE RONDO 3 WAR RECEIVED AT S_R AND A CRACKED HOUSING WAS FOUND AS WELL AS A LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916361 ↗
• MalfunctionJan 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE _ REPAIR DUE TO OPTICAL DAMAGE. UPON FIRST INVESTIGATION, THE RONDO 3 HAD A BROKEN HOUSING AND A LEAKING BATTERY. NO INJURY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21281401 ↗
• 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 LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21099581 ↗
• MalfunctionNov 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE REPAIR. UPON FIRST INVESTIGATION, THE RONDO 3 HAD A BROKEN HOUSING AND A LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650848 ↗
• MalfunctionNov 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE REPAIR. UPON FIRST INVESTIGATION, THE RONDO 3 HAD A BROKEN HOUSING AND A AND LEAKING BATTERY. HULL BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650846 ↗
• MalfunctionSep 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE _ REPAIR. UPON FIRST INVESTIGATION, THE RONDO 3 HAD A BROKEN HOUSING AND A AND LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245365 ↗
• MalfunctionAug 20, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE_REPAIR ON 09-JUL-2024. A BROKEN HOUSING AND A LEAKING BATTERY WERE REPORTED. PER RRF, THE DEVICE SHOWS MECHANICAL PROBLEMS AND SOUND QUALITY ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20005835 ↗
• MalfunctionJul 19, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  DEVICE WAS RECEIVED AT SERVICE_REPAIR ON 24-JUN-2024. UPON FIRST INVESTIGATION, THE RONDO 3 HAD A BROKEN HOUSING AND A LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19780631 ↗
• MalfunctionJul 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE REPAIR ON (B)(6) 2024. UPON FIRST INVESTIGATION, THE RONDO 3 HAD A BROKEN HOUSING AND AN OPEN BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19758686 ↗
• MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 3 AUDIO PROCESSOR WAS RECEIVED AT SERVICE _ REPAIR. PRELIMINARY INSPECTION REVEALED BROKEN HOUSING AND LEAKING BATTERY. PER REPAIR REQUEST FORM, THE HOUSING BROKE AFTER A FALL TO THE GROUND AND THE USER TRIED TO GLUE IT TOGETHER, BUT IT DID NOT WORK ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380005 ↗
• MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 3 AUDIO PROCESSOR WAS RECEIVED AT SERVICE REPAIR. PRELIMINARY INSPECTION REVEALED BROKEN HOUSING AND LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379819 ↗
• MalfunctionMay 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 3 AUDIO PROCESSOR WAS RECEIVED AT SERVICE REPAIR. PRELIMINARY INSPECTION REVEALED BROKEN HOUSING AND LEAKING BATTERY. PER REPAIR REQUEST FORM, THE DEVICE WAS RETURNED DUE TO OPTICAL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19379736 ↗
• MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 3 AUDIO PROCESSOR WAS RECEIVED AT SERVICE _ REPAIR WITH REPORTED ISSUE OF A BROKEN HOUSING AND LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719510 ↗
• MalfunctionJan 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A RONDO 3 AUDIO PROCESSOR WAS RECEIVED AT SERVICE _ REPAIR. UPON PRELIMINARY INSPECTION A BROKEN HOUSING AND LEAKING RECHARGEABLE BATTERY WAS FOUND. PER REPAIR REQUEST FORM, THE DEVICE WAS RETURNED DUE TO MECHANICAL PROBLEMS. TO DATE THERE HAS BEEN NO REPORT OF INJURY FROM THE FIELD AS A RESULT OF THE LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493373 ↗
• MalfunctionJan 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A DEVICE WAS RECEIVED AT HQ WITH A LEAKING BATTERY AND A BROKEN HOUSING. ACCORDING TO THE RRF THE DEVICE WAS SENT IN DUE TO MECHANICAL ISSUES. NO INJURY HAS BEEN REPORTED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18493016 ↗
• MalfunctionDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A RONDO 3 AUDIO PROCESSOR WAS RECEIVED AT HQ WITH A MELTED HOUSING THAT IS PARTIALLY OPEN. ADDITIONALLY A LEAKING RECHARGEABLE BATTERY IS SUSPECTED. REPORTEDLY, THE USER LOST HER RONDO 3 AND FOUND IT A FEW DAYS LATER MELTED IN THE OVEN. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273118 ↗
• MalfunctionDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE WAS RECEIVED AT SERVICE REPAIR AND PRELIMINARY INVESTIGATION REVEALED A LEAKING BATTERY AND A BROKEN HOUSING. PER REPAIR REQUEST FORM THE DEVICE WAS RETURNED AS IT DID NOT WORK AND HAD MECHANICAL PROBLEMS, SPECIFICALLY THAT THE MAGNET COULD NOT BE TAKEN OUT. THERE IS A POSSIBILITY THAT THE DEVICE WAS DROPPED AT SOME POINT. REPORTEDLY, THE PLASTIC/HOUSING SHOWED DAMAGE. THE USER WAS NOT HARMED BY THE LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18273027 ↗

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