Synclara Cough SystemRecalls & reported problems across all models

We found 2 models of Synclara Cough System by Hill-Rom Services Pte. Ltd. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Jul 10, 2024 and Aug 31, 2026 — classified as 1 death, 12 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Crack” (17 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

Most reported Synclara Cough System problems

Synclara Cough System models

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

• Synclara Cough System M08575

  DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
  1 death30 reports
• Synclara Cough System M08086

  DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT
  1 report

Recent Synclara Cough System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pneumonia

  MAUDE report 50531460 ↗
• MalfunctionAug 27, 2026Crack

  Baxter received a report that SYNCLARA SYSTEM, NON-FT SW,HC,NA had cracked 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 50465978 ↗
• MalfunctionJul 27, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50044710 ↗
• MalfunctionJul 3, 2026Crack

  DURING DEVICE EVALUATION ASSESSMENT IT WAS FOUND THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD SMART FILTER BROKEN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25707344 ↗
• MalfunctionJun 24, 2026Crack

  DURING DEVICE EVALUATION ASSESSMENT IT WAS FOUND THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD SMART FILTER BROKEN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611556 ↗
• MalfunctionJun 16, 2026Crack

  DURING DEVICE EVALUATION ASSESSMENT IT WAS FOUND THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD FILTER BROKEN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25523314 ↗
• MalfunctionJun 16, 2026Crack

  BAXTER RECEIVED A REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA HAD FILTER BROKEN. 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 25523249 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A CYANOTIC EPISODE AFTER SYNCLARA THERAPY WAS PERFORMED. IT WAS NOTED THAT THE CUSTOMER WAS TRAINED DURING INITIAL SET UP TO PAUSE AFTER 5 BREATHS; HOWEVER, IT WAS REPORTED DURING THE SESSION THAT THE PATIENTS¿ FACE TURNED BLUE THE CUSTOMER COMPLETED 10 BREATHS IN A ROW. TWO DAYS LATER THE PATIENT HAD A FEVER AND A COLD WHERE PATIENT WAS PRESCRIBED ANTIBIOTICS. THE IFU OF THE DEVICE MENTIONS THAT THE USE OF A FACE MASK MAY RESULT IN DISCOMFORT, VOMITING, OR BREATHLESSNESS IN SOME PATIENTS. CLOSE SUPERVISION THROUGHOUT THE TREATMENT IS NECESSARY WHEN THIS PRODUCT IS USED BY CHILDREN OR PATIENTS WITH PHYSICAL LIMITATIONS OR IMPAIRED COGNITIVE ABILITIES. THERE WAS NO REPORT OF MALFUNCTION OF THE SYNCLARA DEVICE. THE DEVICE REMAINS WITH THE PATIENT, WHO WILL RESUME ITS USE, DECREASING THE THERAPY CYCLES PERFORMED BEFORE A BREAK. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Cyanosis; Respiratory Tract Infection

  MAUDE report 25144135 ↗
• MalfunctionApr 8, 2026Crack

  DURING DEVICE EVALUATION ASSESSMENT IT WAS FOUND THAT SYNCLARA SYSTEM, NON-FT SW, HC, NA HAD SMART FILTER BROKEN. THERE WAS NO PATIENT INJURY OR DEATH REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24823944 ↗
• MalfunctionFeb 26, 2026Crack

  ON 02-FEB-2026, A PATIENT CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM SERVICE, NON-FT SW,HC,NA (PRODUCT CODE M08575A, SERIAL NUMBER (B)(6)), HAD A CRACKED FILTER. 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 24457463 ↗
• MalfunctionFeb 17, 2026Crack

  ON 26-JAN-2026, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA (PRODUCT CODE M08575, SERIAL NUMBER (B)(6)), HAD CRACKED FILTER ON THE SYN CIRC 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 24368780 ↗
• MalfunctionFeb 9, 2026Crack

  ON 15-JAN-2026, A NURSE CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA (PRODUCT CODE M08575, SERIAL NUMBER (B)(6)), HAD 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 24297860 ↗
• MalfunctionJan 21, 2026Crack

  ON 06-JAN-2026, A PATIENT CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM, NON-FT SW,HC,NA (PRODUCT CODE M08575, SERIAL NUMBER (B)(6) ), FILTER WAS 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 24133849 ↗
• MalfunctionJan 7, 2026Crack

  ON 18-DEC-2025, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT SYNCLARA SYSTEM SERVICE, NON-FT SW, HC, NA (PRODUCT CODE M08575A, SERIAL NUMBER (B)(6)), HAD BIOFILTER CRACKED WHERE IT CONNECTS TO THE DEVICE. THE BIOFILTER WAS DISPOSED OF BY HUSBAND. 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 23989775 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PEDIATRIC PATIENT¿S OXYGEN DESATURATED WITH A SYNCLARA COUGH SYSTEM AND EVENTUALLY DEVELOPED PNEUMONIA. ON THE DAY OF THE EVENT, THE TRAINER ADJUSTED THE PATIENT¿S PRESSURES ON THE SYNCLARA DEVICE FROM +/-30 TO +/-40. AFTER THE TRAINER LEFT, THE PATIENT¿S SPO2 DECREASED DOWN INTO THE 70¿S(%). THE PARENTAL CAREGIVERS PLACED THE PATIENT ON THEIR HOME O2 DEVICE AT 2-4 LITERS PER MINUTE (AVERAGING AT 3 LPM) TO MAINTAIN THE MAINTAIN THE PATIENT¿S SPO2; HOWEVER, THE PATIENT CONTINUED TO HAVE TROUBLE KEEPING THEIR SPO2 WITHIN THE ¿NORMAL RANGES.¿ THE PATIENT WAS TRANSPORTED TO THE HOSPITAL WHERE THEY WERE DIAGNOSED WITH PNEUMONIA AND IS WAS PUT ON A VENTILATOR AFTER AN UNKNOWN AMOUNT OF TIME. EIGHT DAYS AFTER EVENT ONSET, THE PATIENT WAS DISCHARGED HOME. THE PATIENT IS CURRENTLY NOT USING THE SYNCLARA DEVICE. FURTHERMORE, THERE WAS NO REPORT OF DEVICE MALFUNCTION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Low Oxygen Saturation; Pneumonia

  MAUDE report 23883036 ↗

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