Ballard* Closed Suction System 99409Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00609038994093), received between Aug 4, 2023 and Sep 18, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Break” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Loose or Intermittent Connection

  It was reported that hospital staff discovered the detached flapper valve one day after the Ballard device had been replaced. There was no reported delay in therapy, harm, or injury associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50819758 ↗
• MalfunctionNov 13, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00126 FOR THE SECOND REPORT. IT WAS REPORTED, THE FLAPPER VALVE DETACHED DURING USE; THERE WAS NO REPORT OF A DELAY IN THERAPY AND/OR HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550254 ↗
• MalfunctionNov 13, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2025-00125 FOR THE FIRST REPORT. IT WAS REPORTED, THE FLAPPER VALVE DETACHED DURING USE; THERE WAS NO REPORT OF A DELAY IN THERAPY AND/OR HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550253 ↗
• MalfunctionOct 30, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00119 FOR THE SECOND REPORT IT WAS REPORTED, THE NURSE DISCOVERED THE FLAPPER VALVE, FROM THE CLOSED SUCTION CATHETER (CSC), WAS FOUND DETACHED IN FRONT OF THE TRACHEOSTOMY CANNULA (TC). THE CSC WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431144 ↗
• MalfunctionOct 30, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2025-00118 FOR THE FIRST REPORT. IT WAS REPORTED, AFTER ABOUT 1-2 HOURS AFTER THE CLOSED SUCTION CATHETER (CSC) WAS REPLACED, THE FLAPPER VALVE WAS FOUND DETACHED ON THE VENTILATOR CIRCUIT. THE CSC WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23431143 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE DISLODGED AND REMAINED IN THE CIRCUIT; THE DEVICE WAS IN USE FOR LESS THAN TWO DAYS. THE NURSE FOUND IT INSIDE THE TUBE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22880021 ↗
• MalfunctionAug 12, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED WHEN THE CLOSED SUCTION CATHETER (CSC) WAS REMOVED FROM THE RESPIRATOR DURING ETCO2 SENSOR REPLACEMENT, THE PRESSURE FROM THE RESPIRATOR CAUSED THE FLAPPER VALVE TO DROP OUT. THIS HAPPENED AFTER THE CSC WAS REPLACED ABOUT 2 HOURS LATER. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789619 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE DISCONNECTED DURING USE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323150 ↗
• MalfunctionJun 24, 2025Material Integrity Problem; Material Integrity Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2025-00060 FOR THE FIRST REPORT IT WAS REPORTED A NEW ENDOTRACHEAL TUBE (ETT) WAS PLACED ON THURSDAY (B)(6) 2025. WHEN REPLACING THE ETT, IT WAS DISCOVERED THE FLAPPER VALVE WAS DAMAGED. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2025 REPORTED, THE PATIENT SUFFERED DECREASED VENTILATION AND TACHYPNEA; THE PATIENT'S CONDITION STABILIZED AFTERWARD.

  Patient problems: Increased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 22322788 ↗
• MalfunctionJun 24, 2025Break; Break

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00061 FOR THE SECOND REPORT. IT WAS REPORTED, A NEW ENDOTRACHEAL TUBE WAS PLACED ON MONDAY (B)(6) 2025, ON THE FOLLOWING DAY, THE FLAPPER VALVE WAS FOUND DURING BRONCHIAL FIBER INSTALLATION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322787 ↗
• MalfunctionApr 10, 2025Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE FELL OUT; IT DID NOT FALL INTO THE TRACHEAL TUBE. THE CATHETER WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21815417 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED; THE DETACHED FLAPPER VALVE WAS FOUND IN THE PATIENT'S THROAT AFTER 2 DAYS AFTER USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047686 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED, AFTER 2 DAYS THE FLAPPER VALVE CAME OUT OF THE PATIENT'S THROAT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21029063 ↗
• MalfunctionNov 21, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED, THE PATIENT FELT UNCOMFORTABLE AND WHEN THE NURSE WENT TO CHECK ON THEM, THEY FOUND THE FLAPPER VALVE WAS IN THE FLEX CONNECTOR. [THE DEVICE WAS] IMMEDIATELY REPLACED AND TREATED; THERE WAS NO INJURY.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746709 ↗
• InjuryJul 12, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE FLAPPER VALVE WAS PLACED AT THE TIME OF [DEVICE] REPLACEMENT. THE CARE PROVIDER NOTED THAT AFTER A FEW MINUTES OF BEING PLACED, THE PATIENT BEGAN CHOKING. THE PATIENT VOMITED THE FLAPPER VALVE FROM THE INCISION SIDE (FROM THE THROAT); AFTER VOMITING THE PATIENT DID NOT HAVE ADDITIONAL PROBLEM(S).

  Patient problems: Choking; Vomiting

  MAUDE report 19729384 ↗
• MalfunctionJun 6, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, AFTER 72 HOURS OF USE THE DEVICE WAS REPLACED. [DURING REPLACEMENT] THE FLAPPER VALVE DISLODGED AND WAS FOUND TO BE IN THE FLEX CONNECTOR. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19477879 ↗
• MalfunctionAug 4, 2023Suction Failure; Suction Failure

  IT WAS REPORTED, THE PATIENT COULD NOT BE ASPIRATED; WHEN SUCTIONING WAS ATTEMPTED, THEY WERE UNABLE TO SUCTION THE PATIENT; THE DEVICE WAS EXCHANGED FOR A NEW ONE AND THEY WERE ABLE TO SUCTION THE PATIENT; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17459361 ↗