Ballard* Closed Suction System 99426Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00609038994260), received between Nov 17, 2024 and Aug 11, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 16, 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.

• MalfunctionAug 11, 2026Break

  It was reported that on the third day of use of the TracheCare 72, hospital staff observed that the flapper valve had detached from the catheter mount side. The detached flapper valve was not found inside the tracheal tube, and no adverse health effects occurred. An additional flapper valve was found at the bedside and was presumed to have also detached.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211821 ↗
• MalfunctionNov 13, 2025Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED WHILE USING THE TRUCK CARE SYSTEM, NP DISCOVERED THAT THE FLAP VALVE HAD COME LOOSE AND FALLEN INTO THE CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550863 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THE FLAPPER VALVE WAS FOUND TO BE DETACHED (ON THE CLOSED SUCTION CATHETER) DURING AN UNSUCCESSFUL SUCTIONING ATTEMPT. THE DETACHED FLAPPER VALVE (FV) DID NOT GO INTO THE PATIENT'S TRACHEA. THERE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974202 ↗
• MalfunctionAug 22, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, DURING SUCTIONING THE CATHETER WAS PULLED UP TO THE GUIDELINE, AND THE FLAPPER VALVE WAS UNABLE TO CLOSE AND [WAS] DANGLING. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 22880003 ↗
• MalfunctionAug 21, 2025Break; Break

  IT WAS REPORTED, THREE (3) HOURS AFTER A NEW CLOSED SUCTION CATHETER (CSC) WAS PLACED THE FLAPPER VALVE DISCONNECTED AND WAS FOUND INSIDE THE CUFFED ENDOTRACHEAL TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868571 ↗
• MalfunctionAug 20, 2025Break; Break

  IT WAS REPORTED, THE CLOSED SUCTION CATHETER (CSC) HAD BEEN IN USE ON THE PATIENT FOR TWO (2) DAYS WHEN IT WAS DISCOVERED THE FLAPPER VALVE WAS ALMOST DETACHED [FROM THE DEVICE]. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22856633 ↗
• MalfunctionAug 12, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE FLAPPER VALVE DISLOCATED AFTER BEING USED FOR 1 DAY; IT WAS FOUND IN THE FLEX CONNECTOR. THERE WAS NO REPORTED INJURY TO THE (SO CALLED) INFECTED PERSON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22789094 ↗
• MalfunctionMay 16, 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 22038638 ↗
• MalfunctionApr 10, 2025Break; Break

  IT WAS REPORTED; THE DISCONNECTED FLAPPER VALVE WAS FOUND INSIDE OF THE FLEX CONNECTOR. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21815423 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED, ON THE 2ND DAY OF USE OF CATHETER, A FLAPPER VALVE WAS DISCONNECTED AND WAS FOUND IN THE FLEX CONNECTOR; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21595071 ↗
• MalfunctionMar 5, 2025Break; Break

  IT WAS REPORTED, THE CONNECTOR ON THE CATHETER BROKE DURING USE ON THE PATIENT; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21529993 ↗
• MalfunctionFeb 28, 2025Material Integrity Problem; Material Integrity Problem

  HOSPITAL STAFF WAS USING THE CATHETER PROPERLY AND NOTICED THAT THE FLAPPER VALVE HAD BEEN REMOVED, JUST BEFORE IT WENT INTO THE PATIENT. THIS COMPLAINT IS REPORTABLE FOR 1 CLOSED SUCTION CATHETER. WHILE NO PATIENT HARM OR INJURY WAS REPORTED, THE REPORT OF A DETACHED FLAPPER VALVE COULD RESULT IN SERIOUS HARM OR INJURY IF IT WERE TO BECOME LODGED IN THE PATIENT'S AIRWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21497916 ↗
• MalfunctionFeb 7, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, ON THE SECOND DAY OF USE, ON THE PATIENT, THE STAFF NOTICED THE FLAPPER VALVE WAS DETACHED AND HAD FALLEN ON THE CATHETER MOUNT SIDE. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21336993 ↗
• MalfunctionJan 17, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER OPENING THE PACKAGE AND ATTACHING THE TRACK CARE 72 TO THE PATIENT, A MEDICAL STAFF HEARD AIR LEAK SOUND, AND UPON CHECKING, SHE FOUND THAT THE INJECTION PORT WAS NOT ATTACHED FROM THE BEGINNING AND WAS LEAKING GILLS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182508 ↗
• MalfunctionJan 9, 2025Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE FELL ON THE FIRST DAY OF USE ON THE PATIENT; IT IS UNCLEAR WHERE THE FLAPPER VALVE WAS FOUND; HOWEVER, IT WAS NOT FOUND IN THE PATIENT¿S AIRWAY. THERE WAS NO REPORTED INJURY AND THE PATIENT'S CONDITION WAS REPORTED TO BE WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118739 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE DETACHED SHORTLY AFTER USE ON THE PATIENT; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21048840 ↗
• MalfunctionDec 19, 2024Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE FELL ON THE FIRST DAY OF USE ON THE PATIENT; IT IS UNCLEAR WHERE THE FLAPPER VALVE WAS FOUND; HOWEVER, IT WAS NOT FOUND IN THE PATIENT'S AIRWAY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20984330 ↗
• MalfunctionNov 26, 2024Break; Break

  IT WAS REPORTED, DURING THE MORNING SUCTION, THE CLEANING SOLUTION SUCTION TECHNIQUE DID NOT GO WELL, AND WHEN THE CIRCUIT WAS CHECKED THE FLAPPER BUBBLE WAS FOUND TO HAVE COME OFF AND HAD ADHERED TO THE FLEX CONNECTOR. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20779889 ↗
• MalfunctionNov 17, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  ADDITIONAL INFORMATION RECEIVED 04DEC2024 REPORTED, THE DETACHED FLAPPER VALVE DID NOT GO INTO THE ENDOTRACHEAL TUBE, IT WAS FOUND IN THE FILTER BETWEEN THE VENTILATOR AND ANESTHESIA CIRCUIT. THE ARTHROSCOPY WAS USED IN AN ATTEMPT TO DISCOVER THE LOCATION OF THE FLAPPER VALVE; NO HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20702905 ↗