BiPAP V30 AutoRecalls & reported problems across all models

We found 2 models of BiPAP V30 Auto by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 8 adverse event reports in the FDA's MAUDE database, received between May 15, 2024 and Apr 3, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (4 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

BiPAP V30 Auto recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 26, 2022Open, Classified

   Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

   Z-1656-2022 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

Most reported BiPAP V30 Auto problems

BiPAP V30 Auto models

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

• BiPAP V30 Auto BiPAP V30 Auto, US

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  1 recall6 reports
• BiPAP V30 Auto 00

  VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING
  1 recall2 reports

Recent BiPAP V30 Auto adverse event reports

The 8 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CUSTOMER THAT A VENTILATOR INOPERATIVE CONDITION WAS REPORTED ON A BIPAP A30 DEVICE. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN (B)(4) DUE TO INTERRUPTIONS AND/OR LOSS OF THERAPY DUE TO A VENTILATION INOPERATIVE ALARM. THERE WAS NO SERIOUS PATIENT HARM OR INJURY THAT OCCURRED OR WAS REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. GOOD FAITH EFFORTS ARE ACTIVELY BEING MADE TO HAVE THE DEVICE RETURNED FOR EVALUATION. IF THE DEVICE IS RETURNED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE EVALUATION RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781364 ↗
• InjuryNov 9, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO THE MANUFACTURER BY A DISTRIBUTOR THAT THE BIPAP V30 AUTO DEVICE CEASED FUNCTIONING DURING ACTIVE THERAPY ON A PATIENT IN THE HOSPITAL/USER FACILITY. THE PATIENT WAS ADMITTED WITH ACUTE ON CHRONIC HYPOXIC AND HYPERCAPNIC RESPIRATORY FAILURE AND WAS PLACED ON THE BIPAP V30 AUTO AT SETTINGS OF S/T 10/5 CMH2O WITH 6 L/MIN OXYGEN BLEED-IN AT APPROXIMATELY 00:58. ABOUT ONE HOUR AFTER THERAPY INITIATION, THE DEVICE SHUT OFF AND DISPLAYED A ¿VENTILATOR INOPERATIVE¿ CONDITION. BASED ON AVAILABLE INFORMATION, THE DEVICE ENTERED AN INOPERATIVE CONDITION DURING USE, RESULTING IN A VENTILATION INTERRUPTION. THIS CONTRIBUTED TO PATIENT DESATURATION AND SUBSEQUENT HYPERCAPNIA REQUIRING INTUBATION. THE EVENT HAS BEEN ASSESSED AS A SERIOUS INJURY PER 21 CFR 803.3(W). THE DEVICE CAUSE/CONTRIBUTION TO THE EVENT IS CONFIRMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AND IS CURRENTLY AWAITING EVALUATION. SHOULD THE DEVICE BE RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SUBMITTED TO PROVIDE THE INVESTIGATION RESULTS.

  Patient problems: Hypoxia

  MAUDE report 23507282 ↗
• MalfunctionAug 7, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP V30 AUTO, DOMESTIC DEVICE ALARMED FOR A VENTILATOR INOPERATIVE ALARM CONDITION. THERE WAS NO HARM OR INJURY ALLEGED. THE DEVICE HAS YET TO BE RETURNED FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE DEVICE WILL BE INCLUDED IN THE FSN 2023-CC-SRC-039

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22737604 ↗
• MalfunctionOct 28, 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 VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20548115 ↗
• MalfunctionOct 28, 2024Degraded; Appropriate Device Problem Term/Code Not Available; Degraded; Appropriate Device Problem Term/Code Not Available

  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 VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE CLINICAL ASSESSMENT STATES THAT BASED ON THE INFORMATION CURRENTLY PROVIDED AND AVAILABLE, NO HARM OR INJURY HAS BEEN SUSTAINED AND THEREFORE FURTHER ANALYSIS OF CAUSE AND/OR CONTRIBUTION OF THE DEVICE TO A SERIOUS INJURY OR DEATH IS NOT APPLICABLE. THE REPORTER NOTES PRE-EXISTING CONDITIONS OF: RESPIRATORY FAILURE, COPD/ASTHMA OR OTHER CHRONIC LUNG DISEASE, HISTORY OF MYOCARDIAL INFARCTION OR CARDIAC ARREST, CONGESTIVE HEART FAILURE, CHRONIC OXYGEN DEPENDENCY. BASED UPON THE INFORMATION PROVIDED, THESE CONDITIONS HAVE BEEN REVIEWED AND ASSESSED AS UNRELATED TO THE DEVICE. 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 20546107 ↗
• MalfunctionSep 19, 2024Unexpected Shutdown; Unexpected Shutdown

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE WAS ALARMING, AND WHEN STAFF ENTERED THE PATIENT'S ROOM, THE DEVICE WAS OFF, AND THE SCREEN WAS BLANK WHILE IN PATIENT USE. THERE WAS NO PATIENT HARM OR INJURY AND WILL BE REPORTED AS A PRODUCT PROBLEM. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20260917 ↗
• MalfunctionAug 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20043027 ↗
• MalfunctionMay 15, 2024Mechanical Problem; Mechanical Problem

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE CUSTOMER WERE "ADVISED TO ENSURE FILTERS ARE CLEAN AND TO UNPLUG THE UNIT SIT FOR TEN MINUTES AND TRY AGAIN. THE CUSTOMER "STATED ITS WORKING FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19325710 ↗

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