REMstar System One 60 Series REMstar Pro C-Flex+, with Humidifier, 60 Series, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00606959030268), received between Dec 21, 2021 and Mar 23, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Degraded” (8 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Degraded

  A REMSTAR PRO C-FLEX+ DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND OBSERVED DETERIORATED FOAM. IN ADDITION, FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY AND DUST/DIRT WAS FOUND INSIDE THE DEVICE. ADDITIONALLY, THE DEVICE WAS SCRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663476 ↗
• MalfunctionJan 14, 2026Degraded

  THE REMSTAR PRO C-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, IT WAS VISUALLY INSPECTED, AND THE ENGINEER FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION INSIDE THE BLOWER KIT, DUST FAIL CONTAMINATION, FLUIDS FAIL CONTAMINATION AND DISPLAYED ERROR CODE: 53 (E-53 ERR_COMP_LOG_SEM_TIMEOUT). THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24071538 ↗
• MalfunctionJan 16, 2025Degraded; Degraded

  A DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND HAS VISUALIZATION OF FOAM PARTICLES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. IN ADDITION TO ABOVE FINDINGS, THERE WAS A PRESENT OF CONTAMINATION IN THE DEVICE, WHICH ARE TOBACCO AND DUST/DIRT. THERE WAS ALSO A PRESENT OF ERROR CODES, WHICH IS 51 IN WHICH IS AN ERROR IN THE PCA. THE DEVICE WAS ROUTED TO SCRAP. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173044 ↗
• MalfunctionAug 6, 2024Degraded; Degraded

  THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE THIRD PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, THE DEVICE LOGS WERE DOWNLOADED AND NO ERRORS CODE WERE FOUND. THERE WAS EVIDENCE OF FOAM PARTICLES DURING THE TESTING OF THE DEVICE. THE SERVICE CENTER ALSO FOUND DUST AND DIRT INSIDE THE DEVICE. THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19921429 ↗
• MalfunctionMar 25, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13905290 ↗
• MalfunctionMar 24, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND BLOWER ASSEMBLY SHOWS EVIDENCE OF DARK COLORED CONTAMINANTS DURING DEVICE INVESTIGATION. THERE WAS NO REPORT OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892567 ↗
• MalfunctionMar 8, 2022Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND DURING EVALUATION AT A THIRD PARTY, THE MAIN PCA, POLLEN FILTER, HUMIDIFIER BASE CABLE, UI KNOB AND SOUND ABATEMENT FOAM WERE REPLACED. THERE WAS NO ALLEGATION OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694869 ↗
• InjuryDec 21, 2021Degraded; Degraded

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP AN ENLARGED LIVER AND KIDNEY ISSUES. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

  Patient problems: Unspecified Hepatic or Biliary Problem; Unspecified Kidney or Urinary Problem

  MAUDE report 13051111 ↗