BiPAP AVAPSRecalls & reported problems across all models
Respironics, Inc. · 13 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 572
- Deaths reported
- 7
- Injuries reported
- 25
- Recalls
- 0
We found 13 models of BiPAP AVAPS by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 572 adverse event reports in the FDA's MAUDE database, received between Aug 2, 2017 and Sep 23, 2026 — classified as 7 deaths, 25 injuries, 540 malfunctions.
The most frequently reported specific device problem is “Degraded” (550 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 AVAPS problems
Device problems
- Degraded550
- Thermal Decomposition of Device9
- Adverse Event Without Identified Device or Use Problem4
- Electrical /Electronic Property Problem3
- Contamination2
- Failure to Power Up2
- Insufficient Device Problem Information2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions517
- Unspecified Respiratory Problem17
- Headache15
- Dyspnea11
- Cancer10
- Dizziness6
- Skin Inflammation/ Irritation6
- Unspecified Kidney or Urinary Problem6
BiPAP AVAPS models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BiPAP AVAPS BiPAP AVAPS C Series, 30cm, INTLVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING274 reports
- BiPAP AVAPS BiPAP AVAPS C Series Core Pack, 30cm, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death83 reports
- BiPAP AVAPS BiPAP AVAPS C Series Core Pack, Heated Tube, 30cm, CAVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING68 reports
- BiPAP AVAPS 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING56 reports
- BiPAP AVAPS. BiPAP AVAPS C Series Core Pack w/Heated Tube, 30cm, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING27 reports
- BiPAP AVAPS BiPAP AVAPS C Series, 30cm, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death23 reports
- BiPAP AVAPS BiPAP AVAPS C Series, 30cm, FRVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING17 reports
- BiPAP AVAPS 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 deaths10 reports
- BiPAP AVAPS BiPAP AVAPS C Series Core Pack, 30cm, CNVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death5 reports
- BIPAP AVAPS 00VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 deaths4 reports
- BiPAP AVAPS BiPAP AVAPS C Series, 25cm, INTLVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 reports
- BiPAP AVAPS BIPAP AVAPS C Series, 30cm, AUVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 report
- BiPAP AVAPS BiPAP AVAPS C Series, ITVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 report
Recent BiPAP AVAPS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863070 ↗MalfunctionSep 22, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856260 ↗MalfunctionSep 14, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762695 ↗MalfunctionSep 14, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50760286 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device
A BiPAP AVAPS device was returned to the service center for evaluation. There was no initial alleged complaint found.During the evaluation conducted at the third-party service center, the device was visually inspected, and no evidence of foam particles was observed. Additionally, the service technician identified a burnt connector, and the device was forwarded to RIQL for further investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50015271 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device; Excessive Heating
A BIPAP AVAPS 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 no evidence of foam degradation was found. Moreover, the device had burnt power connector.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 50015146 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device
A BiPAP AVAPS C Series device was returned to a third-party service center for evaluation. During the evaluation of the device, the service technician observed burnt connector.Due to the alleged malfunction, the device will be returned to the manufacturer's Product Investigation Lab for additional testing. The root cause is not confirmed at this time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013966 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device
A BiPAP AVAPS device was returned to the service center for evaluation. There was no initial alleged complaint found.During the evaluation conducted at the third-party service center, the device was visually inspected, and no evidence of foam particles was observed.Additionally, the service technician identified a burnt connector, and the device was forwarded to RIQL for further investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013424 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device
A BiPAP AVAPS 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. There was no report of serious patient harm or injury. There was no report of medical intervention. During the evaluation of the device at the third-party service center, the device was visually inspected and found a burned connector. The device was forwarded to the PIL for further investigation. The manufacturer's investigation is ongoing. A follow-up report will be submitted when the manufacturer's investigation is complete.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003771 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device
A device was returned to a third-party service center and during the evaluation of the device, the third-party service center visually inspected the device and found no evidence of foam degradation. There were secondary findings that the unit's power connector was burnt. The device was forwarded to RIQL. The manufacturer's investigation is ongoing. A supplemental follow-up report will be submitted when the manufacturer's investigation is complete.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50003197 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device
A device was returned to a third-party service center and during the evaluation of the device, the third-party service center visually inspected the device and found no evidence of foam degradation. There were secondary findings that the unit's power connector was burnt.The device was forwarded to RIQL. The manufacturer's investigation is ongoing. A supplemental follow-up report will be submitted when the manufacturer's investigation is complete.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50000758 ↗MalfunctionJul 7, 2026Degraded
A BIPAP AVAPS C SERIES DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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 25739372 ↗MalfunctionJul 7, 2026Degraded
A BIPAP AVAPS 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 EXTREME DIRT AND MOISTURE CONTAMINATION 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. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25734849 ↗MalfunctionJul 4, 2026Degraded
A BIPAP AVAPS 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, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES AND FOAM DEGRADATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25709347 ↗MalfunctionJul 3, 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 AVAPS 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. ADDITIONALLY, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25708371 ↗
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 18, 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