BiPAP S/T C-SeriesRecalls & reported problems across all models

We found 7 models of BiPAP S/T C-Series by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 447 adverse event reports in the FDA's MAUDE database, received between Nov 30, 2017 and Sep 24, 2026 — classified as 7 deaths, 56 injuries, 384 malfunctions.

The most frequently reported specific device problem is “Degraded” (436 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BiPAP S/T C-Series problems

BiPAP S/T C-Series models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BiPAP S/T C-Series BiPAP S/T C Series Core Pack, 30cm, US

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  1 death200 reports
• BiPAP S/T C-Series BiPAP S/T C Series, 30cm, INTL

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  1 death121 reports
• BiPAP S/T C-Series BiPAP S/T C Series Core Pack w/Heated Tube, 30cm

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  1 death62 reports
• BiPAP S/T C-Series BiPAP S/T C Series, 30cm, US

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  51 reports
• BiPAP S/T C-Series BiPAP S/T C Series, 30cm, GB

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  3 deaths6 reports
• BiPAP S/T C-Series BiPAP S/T C Series, 25cm, INTL

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  5 reports
• BiPAP S/T C-Series BiPAP S/T C Series Core Pack, 30cm, CN

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  1 death2 reports

Recent BiPAP S/T C-Series adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Degraded

  A 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. The device was not in patient use.During the evaluation of the device, the third-party service center visually inspected the device and found evidence of foam degradation and dirt and moisture contamination.Additionally, the evaluation of the device data identified unrelated error codes. These error codes are consistent with normal device operation and expected use conditions and are not considered reportable under medical device reporting requirements. No evidence was identified to suggest that these error codes contributed to or caused the reported event.The device has been scrapped.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 50884604 ↗
• MalfunctionSep 23, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873364 ↗
• MalfunctionSep 23, 2026Degraded

  A BiPAP S/T device was returned 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, the service technician observed visible foam particles. Additionally, the service technician also noted contamination. The device was scrapped by the service center after the evaluation was completed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869180 ↗
• MalfunctionAug 11, 2026Degraded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202437 ↗
• MalfunctionAug 11, 2026Degraded

  A BiPAP S/T 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 visible foam particles were observed. Additionally, the patient¿s complaint was confirmed, and the device was scrapped. There was evidence of contamination.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50202195 ↗
• MalfunctionJul 3, 2026Degraded

  A BIPAP S/T DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703261 ↗
• MalfunctionJul 3, 2026Degraded

  A BIPAP S/T DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703259 ↗
• MalfunctionJul 3, 2026Degraded

  A BIPAP S/T C SERIES 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, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702055 ↗
• MalfunctionJul 3, 2026Degraded

  A BIPAP S/T C SERIES DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM PARTICLES WAS FOUND. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25702030 ↗
• MalfunctionJul 3, 2026Degraded

  A BIPAP S/T WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25701458 ↗
• MalfunctionJul 2, 2026Degraded

  A BIPAP S/T C SERIES 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, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699987 ↗
• MalfunctionJul 2, 2026Degraded

  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. A BIPAP S/T DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM PARTICLE WAS FOUND. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699702 ↗
• MalfunctionJul 2, 2026Degraded

  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. A BIPAP S/T DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM PARTICLE WAS FOUND. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25699698 ↗
• MalfunctionJul 2, 2026Degraded

  A BIPAP S/T C SERIES 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 VISIBLE FOAM DEGRADATION WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25697608 ↗
• MalfunctionJul 2, 2026Degraded

  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. A BIPAP S/T C SERIES DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS FOUND. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25693087 ↗

Other Respironics, Inc. products

• REMstar System One 60 Series92 models · 37,934 reports
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• Trilogy46 models · 21,644 reports · 11 recalls
• Trilogy Evo20 models · 5,473 reports · 12 recalls
• Trilogy 1008 models · 5,088 reports
• BiPAP System One 60 Series40 models · 4,599 reports
• BiPAP A4037 models · 1,606 reports · 3 recalls