BiPAP STRecalls & reported problems across all models
Respironics, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 63
- Deaths reported
- 6
- Injuries reported
- 6
- Recalls
- 0
We found 5 models of BiPAP ST by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2017 and Jun 30, 2026 — classified as 6 deaths, 6 injuries, 51 malfunctions.
The most frequently reported specific device problem is “Degraded” (55 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
Reports received per month, all models
Most reported BiPAP ST problems
Device problems
- Degraded55
- Adverse Event Without Identified Device or Use Problem2
- Failure to Power Up2
- Electrical /Electronic Property Problem1
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Chronic Obstructive Pulmonary Disease (COPD)3
- Dyspnea3
- Unspecified Respiratory Problem3
- Bronchitis2
- Cardiac Arrest2
- Dizziness2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
BiPAP ST models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BiPAP ST 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING34 reports
- BiPAP ST 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death14 reports
- BiPAP ST 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING5 deaths12 reports
- BiPAP ST BiPAP S/T C Series Core Pack w/Heated Tube, AHPVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 reports
- BiPAP ST 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 report
Recent BiPAP ST adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 30, 2026Degraded
A BIPAP S/T C SERIES 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. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED 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 CAUSE THE REPORTED EVENT. IT WAS OBSERVED THAT SOME PORT COVERS OR ACCESSORY DOORS WERE MISSING. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25662223 ↗MalfunctionJun 26, 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, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND OBSERVED VISIBLE FOAM PARTICLES. 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 WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25642686 ↗MalfunctionJun 26, 2026Degraded
A BIPAP S/T DEVICE WAS RETURNED TO THE 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. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND.DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES.ADDITIONALLY, THE DEVICE WAS SCRAPPED AND 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25642121 ↗MalfunctionMay 22, 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. 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 WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25260888 ↗MalfunctionMar 3, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24493968 ↗MalfunctionFeb 27, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468199 ↗MalfunctionFeb 27, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24468194 ↗MalfunctionFeb 24, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437212 ↗MalfunctionFeb 24, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437210 ↗MalfunctionFeb 24, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24426852 ↗MalfunctionFeb 23, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24424751 ↗MalfunctionFeb 23, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24412617 ↗MalfunctionFeb 23, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411843 ↗MalfunctionFeb 23, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411839 ↗MalfunctionFeb 20, 2026Degraded
A DEVICE WAS RETURNED TO 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 FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24399665 ↗
Other Respironics, Inc. products
- REMstar System One 60 Series92 models · 37,934 reports
- Philips Trilogy Ventilator90 models · 36,113 reports · 22 recalls
- Philips DreamStation190 models · 32,422 reports
- 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page