Volara SystemRecalls & reported problems across all models

We found 5 models of Volara System by Hill-Rom Services Pte. Ltd. in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Oct 3, 2024 and Sep 29, 2026 — classified as 13 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Crack” (7 reports).

8 FDA recall records name at least one of these models by its device identifier, 6 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

Volara System 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 3, 2026Open, Classified

   Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.

   Z-3257-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. May 21, 2026Open, Classified

   There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

   Z-2551-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. May 21, 2026Open, Classified

   There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

   Z-2550-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. May 21, 2026Open, Classified

   There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

   Z-2549-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

5. May 21, 2026Open, Classified

   There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.

   Z-2548-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

6. Feb 18, 2026Open, Classified

   Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.

   Z-1637-2026 · Root cause: Process control · Recall details · FDA record ↗

7. Apr 26, 2022Terminated

   There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

   Z-1139-2022 · Root cause: Device Design · Recall details · FDA record ↗

8. Apr 26, 2022Terminated

   There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

   Z-1138-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported Volara System problems

Volara System models

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

• Volara System M08473

  DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
  3 recalls0 reports
• Volara System M07937

  DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
  2 recalls0 reports
• Volara System M08085

  DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
  2 recalls0 reports
• Volara System M08594A

  DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
  1 recall2 reports
• Volara System M08594

  DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
  19 reports

Recent Volara System adverse event reports

The 15 most recent reports across all models, 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 8, 2026Use of Device Problem; Insufficient Flow or Under Infusion; Insufficient Device Problem Information

  IT WAS REPORTED THAT AROUND FEBRUARY THE PATIENT WAS DIAGNOSED WITH CAVITARY PNEUMONIA PRESUMABLY DUE TO VOLARA DEVICE NOT FUNCTIONING PROPERLY. IT WAS REPORTED THAT VOLARA DEVICE HAS ABOUT TWO MONTHS NOT FUNCTIONING PROPERLY, SOUNDING QUIETER, LESS STRONG AND DIFFERENT THAN IT USED TO. DAYS AFTER THE EVENT WAS REPORTED, THE VOLARA AND CIRCUIT WAS REPLACED BY THE TRAINER WHO NOTED THE PRESENCE OF WATER IN THE CIRCUIT AND THE NEBULIZER TUBING DURING THE RETRAINING SESSION. PATIENT'S PULMONOLOGIST INDICATED THE PATIENT HAD PUS IN A CAVITY IN HIS LUNG AND WAS PUT ON ANTIBIOTIC. THE PATIENT WAS GIVEN A NEW DEVICE AND THERAPY WITH THE VOLARA HAS BEEN CONTINUED AS PRESCRIBED. THE EXACT CAUSE OF THE EVENT IS UNKNOWN AT THE MOMENT AND NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Pneumonia

  MAUDE report 24822656 ↗
• 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 20, 2026Crack

  ON (B)(6) 2026, A PATIENT CONTACTED TECHNICAL SERVICE TO REPORT THAT VOLARA SYSTEM SERVICED, HC,NA (PRODUCT CODE M08594A, SERIAL NUMBER (B)(6)), HAD SMART 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 24651026 ↗
• 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 ↗

Other Hill-Rom Services Pte. Ltd. products

• The VestSystem5 models · 42 reports
• Synclara Cough System2 models · 31 reports