RONDO 3 Me1550 (AXIAL) black 39909Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09008737399092), received between Oct 24, 2024 and Oct 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 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 23335167 ↗
• 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 23321336 ↗
• 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 23321325 ↗
• MalfunctionOct 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS SENT TO SERVICE _ REPAIR FOR REPAIR. UPON PRELIMINARY INVESTIGATION A BROKEN AND LEAKING BATTERY WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23207607 ↗
• MalfunctionOct 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE DEVICE WAS SENT TO SERVICE REPAIR FOR REPAIR. UPON PRELIMINARY INVESTIGATION A BROKEN AND LEAKING BATTERY WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23207445 ↗
• MalfunctionJan 23, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE DEVICE WAS RECEIVED AT SERVICE REPAIR. UPON FIRST INVESTIGATION, THE RONDO 3 HAD A BROKEN HOUSING AND RESIDUE OF A LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21217224 ↗
• MalfunctionOct 24, 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 20520556 ↗

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. Mi100
• 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