Volara System M08594Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00887761984578), received between Oct 3, 2024 and Sep 29, 2026 — classified as 12 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fluid/Blood Leak

  Patient problems: Respiratory Tract Infection

  MAUDE report 50939067 ↗
• MalfunctionAug 28, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50489080 ↗
• InjuryJul 27, 2026Leak/Splash

  It was reported that following Volara device training on (b)(6) 2025, the patient experienced a leaking nebulizer cup and discontinued use of the device due to medication leakage and lack of perceived therapeutic benefit. The patient, an 81-year-old female with a history of bronchiectasis, reported three bronchiectasis exacerbations that temporally coincided with device use; however, specific dates could not be recalled. The reported exacerbations were treated with Levaquin, Azithromycin, and Amoxicillin. The patient was uncertain whether a circuit-related issue contributed to the events. The exact cause of the exacerbations remains unknown; however, device contribution cannot be excluded. The patient requested in-home retraining and a circuit exchange. A replacement circuit and return packaging were provided, and the device remains with the patient pending re-education and resumption of therapy. No further information was available at the time of this report.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50015178 ↗
• MalfunctionMay 26, 2026Crack

  BAXTER RECEIVED A REPORT THAT VOLARA SYSTEM,HC,NA HAD BIO FILTER CRACKED. THIS OCCURRED AT HOME DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25291672 ↗
• MalfunctionMay 18, 2026Crack

  BAXTER RECEIVED A REPORT THAT VOLARA SYSTEM,HC,NA HAD BROKEN CIRCUIT FILTER. THIS OCCURRED AT HOME BEFORE USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211202 ↗
• MalfunctionMay 14, 2026Crack

  A REPORT WAS MADE THAT VOLARA SYSTEM,HC,NA HAD FILTER CRACKED . THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT. .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25167158 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED ATRIAL FIBRILLATION (A-FIB) AFTER USING THE VOLARA SYSTEM. PATIENT CALLED CLINICAL SUPPORT AS HER MEDICATION DID NOT SEEM TO BE NEBULIZING FULLY. DURING THE PHONE CONVERSATION THE PATIENT MENTIONED THAT THREE MONTHS AGO THEY WENT TO ER VIA AMBULANCE DUE TO A-FIB, THIS OCCURRED TWO HOURS AFTER USING THE VOLARA DEVICE. THE PATIENT NOTED TO HAVE EXPERIENCED ¿A COUPLE MORE A-FIB EPISODES WHILE HOSPITALIZED¿ AND THE PATIENT BELIEVED IT WAS ¿DUE TO THE SEVERITY OF HER COUGHING¿. FOUR DAYS AFTER ADMISSION, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND WAS PUT ON TWO HEART MEDICATIONS AND WILL BE FOLLOWING UP WITH A CARDIOLOGIST. NO ADDITIONAL TREATMENT WAS REPORTED, AND WILL CONTINUE USING THE DEVICE. THE PATIENT¿S HEALTHCARE TEAM WAS UNCERTAIN IF THE VOLARA DEVICE CAUSED OR CONTRIBUTED TO THE EVENT OF ATRIAL FIBRILLATION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Atrial Fibrillation

  MAUDE report 24811003 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT EXPERIENCED ¿SUDDEN SIGNIFICANT LUNG BLEEDING¿ ATTRIBUTED TO A VOLARA SYSTEM. THE PATIENT STARTED USING THE VOLARA SYSTEM FOURTY SEVEN DAYS PRIOR TO THE DATE OF THIS REPORT. TWELVE DAYS LATER THE PATIENT COMPLAINED OF A ¿SUDDEN SIGNIFICANT LUNG BLEEDING¿. THE PATIENT CONFIRMED THAT THE VOLARA DEVICE WAS NOT USED ON THE DAY OF THE EVENT. THE PATIENT ATTENDED THE HOSPITAL, AND THE PATIENT UNDERWENT ¿A FULL-WORK-UP¿ INCLUDING A CT SCAN AND WAS PROVIDED ¿MEDICATIONS AND ANTIBIOTICS.¿ IT IS ALSO NOTED THAT THE PATIENT¿S HOSPITAL TEAM INSTRUCTED THE PATIENT TO DISCONTINUE TAKING HIS PRESCRIBED ELIQUIS, AS WELL AS DISCONTINUE USE OF THE VOLARA DEVICE. THE PATIENT CONFIRMED THAT THERE WERE NO DEVICE ERRORS, AND NO ALLEGATION OF MALFUNCTION. THE DEVICE IS BEING RETURNED DUE TO THE PATIENT¿S DISCONTINUANCE OF USE. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bronchial Hemorrhage

  MAUDE report 24802420 ↗
• MalfunctionMar 13, 2026Crack

  ON 19-FEB-2026, A PATIENT CONTACTED TECHNICAL SERVICE TO REPORT THAT VOLARA SYSTEM, HC, NA (PRODUCT CODE(B)(4), SERIAL NUMBER (B)(6)), HAD FILTER CRACKED WHERE IT CONNECTS TO THE PORT. THIS OCCURRED AT HOME BEFORE USE. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594298 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT SUSTAINED A SPONTANEOUS PNEUMOTHORAX WITH A VOLARA SYSTEM. ON THE DATE OF THE EVENT, THE PATIENT COMPLETED THEIR REGULAR VOLARA TREATMENT AT 00:06 WITHOUT INCIDENT. THE PATIENT REPORTED THEY WERE ¿GETTING READY FOR BED¿ AND ALLEGEDLY BECAME ¿SHORT OF BREATH AND HAD PAIN IN THEIR LUNG.¿ THE PATIENT ¿DID NOT THINK MUCH OF IT,¿ DUE TO THEIR HISTORY OF LUNG PAIN. THE FOLLOWING DAY, THE PATIENT STILL FELT ¿EXTREMELY SHORT OF BREATH WITH LUNG PAIN¿ AND AN AMBULANCE WAS CALLED. THE PATIENT WAS ADMITTED TO HOSPITAL. WHILE HOSPITALIZED THE PATIENT WAS FOUND TO HAVE A COLLAPSED LEFT LUNG WHICH REQUIRED A CHEST TUBE AND RECEIVED UNSPECIFIED MEDICAL TREATMENT. THE PATIENT WAS DISCHARGED EIGHT DAYS LATER. THE PATIENT CONFIRMED THAT THEY WILL NOT BE USING THE VOLARA DEVICE UNTIL THEY RECEIVED CLEARANCE FROM THEIR PULMONOLOGIST. FURTHERMORE, BASED ON THE PATIENT¿S HISTORY OF EXPERIENCING PNEUMOTHORAX EPISODES SIX YEARS PRIOR TO USE OF THE DEVICE AND ALSO AGAIN WHILE VOLARA THERAPY WAS PAUSED, IT CAN BE REASONABLY CONCLUDED THAT THE REPORTED EVENT WAS LIKELY DUE TO PATHOPHYSIOLOGY OF THE PATIENT¿S MEDICAL CONDITION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 23425338 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEVELOPED PSEUDOMONAS ATTRIBUTED TO A VOLARA SYSTEM. THE PATIENT STATED THEY COULDN¿T GET THE WATER OUT OF THE TUBING, AND THIS WAS THE CAUSE OF THE PATIENT¿S PSEUDOMONAS INFECTION. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS. TREATMENT OF THE INFECTION WAS NOT REPORTED. THE PATIENT HAS NOT RESTARTED THE VOLARA SYSTEM UNTIL THEY SEE THEIR NEW PULMONOLOGIST IN APPROXIMATELY SIX WEEKS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Respiratory Tract Infection

  MAUDE report 23408515 ↗
• MalfunctionSep 3, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  BAXTER RECEIVED A REPORT STATING THAT VOLARA SYSTEM COPPER WIRE IS SHOWING ON POWER CORD. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22954627 ↗
• MalfunctionAug 8, 2025Crack; Crack

  BAXTER RECEIVED A REPORT STATING THAT VOLARA SYSTEM FILTER WAS CRACKED. THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751126 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE CLINICAL TRAINER THAT A SCHOOL AGED PATIENT DESATURATED WHILE USING THE VOLARA SYSTEM. THE CLINICAL TRAINER WAS SETTING UP THE VOLARA FOR TRAINING ON THE PATIENT AND WITHIN 30 SECONDS OF INITIATING THE VOLARA, THE PATIENT'S OXYGEN SATURATION DROPPED TO 56% WHILE USING THE CPEP MODE ON ROOM AIR. THE TRAINER STOPPED THE THERAPY, AND THE PATIENT¿S PARENTAL CAREGIVER DELIVERED VENTILATION WITH A BAG VALVE MASK (AMBU BAG). THE PATIENT'S OXYGEN SATURATION INCREASED ABOVE 90% WITHOUT THE NEED FOR SUPPLEMENTAL O2 ADMINISTRATION. THE BAXTER CLINICAL SUPPORT SPECIALIST ADVISED THE TRAINER TO USE THE CHFO MODE; HOWEVER, WITHIN 30 SECONDS, THE PATIENT'S OXYGEN SATURATION DROPPED AGAIN, TO 76% ON ROOM AIR. THE PATIENT¿S PARENTAL CAREGIVER HAD TO BAG THE PATIENT AGAIN. THE PATIENT'S SPO2 IMPROVED TO THE MID 90¿S% IN LESS THAN 30 SECONDS. IT WAS NOTED THAT THE PATIENT'S BASELINE OXYGEN SATURATION VALUES ARE IN THE MID 90'S% ON ROOM AIR AND UTILIZES SUPPLEMENTAL OXYGEN ONLY WHEN REQUIRED. ADDITIONALLY, THERE WAS NO REPORT OF A DEVICE MALFUNCTION. THE EXACT CAUSE IS UNDETERMINED AT THIS TIME; HOWEVER, IT CAN BE REASONABLY CONCLUDED THAT THE REPORTED EVENT WAS LIKELY DUE TO TH

  Patient problems: Low Oxygen Saturation

  MAUDE report 21439055 ↗
• InjuryJan 13, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT EXPERIENCED THRUSH DURING USE OF VOLARA SYSTEM. THE PATIENT STARTED USING THE VOLARA SYSTEM NINETY FOUR DAYS PRIOR TO THE DATE OF THIS REPORT. SEVEN DAYS LATER THE PATIENT COMPLAINED OF A ¿HOARSE VOICE¿. THE PATIENT CONTINUED USING THE DEVICE AT LOWER DEVICE SETTINGS. THIRTY ONE DAYS LATER, THE PATIENT VISITED THEIR DENTIST AND WAS DIAGNOSED WITH THRUSH. THE DENTIST PRESCRIBED DIFLUCAN FOR TWO WEEKS. NINETEEN DAYS AFTER THE VISIT TO THE DENTIST, THE PATIENT VISITED AN UNKNOWN DOCTOR DUE TO ¿PERSISTENT SYMPTOMS¿. THE PATIENT WAS ADVISED TO ¿STOP USING THE VOLARA SYSTEM, RE-ACCESS IF NOT BETTER THEN WOULD NEED TO SEE AN EAR NOSE AND THROAT PHYSICIAN¿. THE PATIENT DECLINES ANY MACHINE MALFUNCTION. HOWEVER, AFTER A FOLLOW-UP CALL BY A RESPIRATORY CLINICIAN, FOUND THAT THE PATIENT WAS NOT CLEANING THE VOLARA DEVICE ACCORDING TO THE DEVICE'S INSTRUCTIONS. THE PATIENT REPORTED CLEANING THE DEVICE CIRCUIT 2-3 TIMES SINCE THE INITIATION OF THERAPY; THOUGH, HAS NOT CHANGED THE CIRCUIT. ADDITIONALLY, THE PATIENT WAS NOT CLEANING THE DEVICE¿S MOUTHPIECE, NEBULIZER CUP, OR THE DEVICE¿S CORRUGATED CIRCUIT TUBING. THE DEVICE¿S INSTRUCTIONS FOR USE STATE THE FOLLOWING F

  Patient problems: Glossitis

  MAUDE report 21146407 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT INITIATED THE USE OF VEST, VOLARA AND NEBULIZERS THERAPIES AFTER BEING DISCHARGED FROM THE HOSPITAL IN (B)(6) 2024 AND WAS DIAGNOSED WITH PECTUS DEFORMITY DURING AN ONCOLOGY APPOINTMENT ON (B)(6) 2024. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Deformity/ Disfigurement

  MAUDE report 20361894 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED BY THE BAXTER SALES TEAM, DURING A MEETING WITH THE CUSTOMER, THAT FIVE CYSTIC FIBROSIS PATIENTS WHO ARE CURRENTLY USING THE VOLARA DEVICE, ARE FREQUENTLY READMITTED FOR INFECTION SUCH AS PSEUDOMONAS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Bacterial Infection

  MAUDE report 20358543 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED BY THE BAXTER SALES TEAM, DURING A MEETING WITH THE CUSTOMER, THAT FIVE CYSTIC FIBROSIS (CF) PATIENTS WHO ARE CURRENTLY USING THE VOLARA DEVICE, ARE FREQUENTLY READMITTED FOR INFECTION SUCH AS PSEUDOMONAS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

  Patient problems: Bacterial Infection

  MAUDE report 20358530 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED BY THE BAXTER SALES TEAM, DURING A MEETING WITH THE CUSTOMER, THAT FIVE CYSTIC FIBROSIS PATIENTS WHO ARE CURRENTLY USING THE VOLARA DEVICE, ARE FREQUENTLY READMITTED FOR INFECTION SUCH AS PSEUDOMONAS. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

  Patient problems: Bacterial Infection

  MAUDE report 20358504 ↗