RONDO 2 Processor Unit 30459Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 09008737304591), received between Aug 14, 2019 and Mar 26, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (42 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Fluid/Blood Leak

  DURING THE ANALYSIS IN SERVICE AND REPAIR, A BROKEN DEVICE HOUSING WAS OBSERVED AND A LEAKING RECHARGEABLE BATTERY INSIDE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24696536 ↗
• MalfunctionSep 25, 2025Overheating of Device; Overheating of Device

  USER REPORTED THAT WHILE CHARGING, THE DEVICE STARTED TO HEAT UP AND SMOKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23140841 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  PRELIMINARY DEVICE INVESTIGATION SHOWED A BROKEN HOUSING AND A LEAKING BATTERY. ACCORDING TO THE RRF THERE WAS AN OPTICAL DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369993 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE AUDIO PROCESSOR RONDO 2 WAS NOT WORKING. THE MAGNET WOULD NOT COME OUT DUE TO PRESSURE AND WAS FORCED APART. PRELIMINARY DEVICE INVESTIGATION SHOWED A BROKEN HOUSING AND LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369984 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  PRELIMINARY DEVICE INVESTIGATION SHOWED A CRACKED HOUSING AND A LEAKING BATTERY. ACCORDING TO THE RRF THE DEVICE HAD A CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369978 ↗
• MalfunctionFeb 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  SERVICE REPAIR DISCOVERED A RONDO 2 AUDIO PROCESSOR WITH A BROKEN HOUSING AND A LEAKING BATTERY. THERE HAS BEEN NO REPORT FROM THE FIELD OF ANY PATIENT CONTACT TO BATTERY CHEMISTRY OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21409023 ↗
• MalfunctionOct 24, 2024Fluid/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 20520422 ↗
• MalfunctionSep 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE WAS RECEIVED AT SERVICE_REPAIR ON 19-AUG-2024 DUE TO MECHANICAL PROBLEMS. UPON FIRST INVESTIGATION, A LEAKING BATTERY AND A BROKING WELDING SEAM WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20180828 ↗
• MalfunctionSep 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A RONDO 2 WAS RECEIVED AT SERVICE _ REPAIR WITH A LEAKING BATTERY AND A BROKEN WELDING SEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135241 ↗
• MalfunctionMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE WAS RECEIVED AT SERVICE AND REPAIR ON 13.MAR.2024. IT WAS FOUND THAT THE DEVICE SHOW OPENED HOUSING AND A LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339656 ↗
• MalfunctionMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE WAS RECEIVED AT SERVICE_REPAIR ON (B)(6) 2024. UPON FIRST INVESTIGATION, IT WAS FOUND OUT THAT THE DEVICE HAS AN OPENED HOUSING AND A LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339511 ↗
• MalfunctionApr 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT HQ WITH A BROKEN CASE PART AND A LEAKING BATTERY. THE USER WAS REPORTEDLY NOT HARMED BY THE LEAKING BATTERY.

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

  MAUDE report 19048755 ↗
• MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS SENT TO HQ DUE TO NO FUNCTION. PRELIMINARY DEVICE INVESTIGATION REVEALED A BROKEN HOUSING AND A LEAKING BATTERY. ACCORDING TO THE FIELD THE DEVICE DID NOT HAVE A LEAKING BATTERY AT THE TIME THE DEVICE WAS SENT BACK TO HQ AND THEREFORE NO USER WAS HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18880532 ↗
• MalfunctionMar 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A RONDO 2 DEVICE WITH A BROKEN HOUSING AND A LEAKING BATTERY WAS RECEIVED AT HQ. TO DATE NO INJURY DUE TO CONTACT WITH LEAKING ELECTROLYTE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18837767 ↗
• MalfunctionFeb 16, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 2 AUDIO PROCESSOR WAS RECEIVED AT SERVICE _ REPAIR DUE TO NON-FUNCTION. PRELIMINARY INSPECTION REVEALED A BROKEN HOUSING AND A LEAKING BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719511 ↗
• MalfunctionFeb 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE WAS RECEIVED AT SERVICE_REPAIR ON (B)(6) 2024. A BROKEN HOUSING AND A LEAKING BATTERY WERE REPORTED. THERE WAS NO VISIBLE LEAKAGE ON THE DEVICE. THE USER DID NOT COME INTO DIRECT CONTACT WITH THE LEAKING BATTERY. THE DEVICE WAS RETURNED DUE TO THE BROKEN HOUSING. THE AP WAS TRAPPED UNDER DEBRIS AFTER THE EARTHQUAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702592 ↗
• MalfunctionNov 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 2 AUDIO PROCESSOR WAS RECEIVED BY SERVICE AND REPAIR AND UPON PRELIMINARY INVESTIGATION A DAMAGED HOUSING AND LEAKING BATTERY WAS NOTED. ACCORDING TO THE REPAIR REQUEST FORM, THE DEVICE WAS RETURNED BECAUSE THE WELDING SEAM WAS BROKEN. TO DATE NO INJURIES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18098847 ↗
• MalfunctionNov 9, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 2 AUDIO PROCESSOR WAS RECEIVED BY SERVICE AND REPAIR AND IT WAS FOUND THAT THE HOUSING WAS BROKEN AND THE RECHARGEABLE BATTERY INSIDE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18098751 ↗
• MalfunctionSep 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 2 WAS RECEIVED BY SERVICE AND REPAIR AND IT WAS FOUND THAT THE HOUSING WAS BROKEN AND THE RECHARGEABLE BATTERY INSIDE WAS LEAKING. IT WAS REPORTED THAT THE DEVICE FELL TO THE GROUND WHEN THE USER HAD JUMPED. THERE WERE NO INJURIES REPORTED RELATED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797820 ↗
• MalfunctionSep 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 2 WAS RETURNED TO SERVICE AND REPAIR DUE TO WELDING SEAM BEING BROKEN. UPON PRELIMINARY INSPECTION AT SERVICE IT WAS CONFIRMED THE HOUSING WAS OPENED AND THE RECHARGEABLE BATTERY INSIDE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743732 ↗
• MalfunctionSep 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE RONDO 2 WAS RETURNED TO SERVICE AND REPAIR DUE TO HOUSING BEING BROKEN. UPON PRELIMINARY INSPECTION AT SERVICE IT WAS CONFIRMED THE HOUSING WAS OPENED AND THE RECHARGEABLE BATTERY INSIDE WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17743731 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DEVICE WAS RECEIVED AT SERVICE_REPAIR ON 21-JUN-2023. THE AUDIO PROCESSOR WAS SENT IN FOR REPAIR DUE TO OPTICAL DAMAGES AND IT WAS NOT RECOGNIZED BY THE FITTING SOFTWARE. INITIAL DEVICE INVESTIGATION SHOWED A DAMAGED/OPENED HOUSING AND A LEAKING BATTERY INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341433 ↗
• MalfunctionMay 19, 2023Fluid/Blood Leak; Battery Problem; Fluid/Blood Leak; Battery Problem

  THE USER REPORTED THAT THE DEVICE HAS AN ISSUE WITH HOLDING ITS CHARGE AND THAT THE BATTERY LIFE IS SHORT. FURTHERMORE, THEY DISCOVERED A GEL-LIKE LEAKAGE ON THE SURFACE OF THE MAGNET. THE USER WAS NOT INJURED BY ANY LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968187 ↗
• MalfunctionMar 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE USER'S RONDO 2 AUDIO PROCESSOR REPORTEDLY FELL ON THE GROUND AND WAS DAMAGED. THE AUDIO PROCESSOR COULD NOT BE CONNECTED TO MAX AFTERWARDS. THE LED IS REPORTEDLY BLUE AND BLINKING CONSTANTLY. THERE WAS NO HARM SUSTAINED AND THE HEARING PERFORMANCE PRIOR WAS QUITE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16457978 ↗
• MalfunctionDec 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE FAMILY OF THE USER REPORTED THAT THE MAGNET OF THE RONDO 2 WAS CHANNELED UP AND CRACKED THE HOUSING. THE MAGNET IS STUCK AND CANNOT BE REMOVED. REPORTEDLY, THE USER DID NOT FALL OR FALL ON THE DEVICE AND IS HANDLING THE DEVICE AS INSTRUCTED. ADDITIONALLY, THE DEVICE RUNS OUT OF BATTERY QUICKLY. A TEMPORARILY LOANER DEVICE WAS PROVIDED TO THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922320 ↗

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-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