Ballard* Closed Suction System 99430Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00609038994307), received between Sep 12, 2023 and Nov 13, 2025 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE FLAPPER VALVE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23550860 ↗
• MalfunctionJul 24, 2025Gas/Air Leak; Gas/Air Leak

  AN AIR LEAK WAS REPORTED DURING USE ON A PATIENT; THE DEVICE WAS REPLACED AND THE ISSUE RESOLVED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22587644 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE DISCONNECTED DURING THE USE ON A PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22322244 ↗
• MalfunctionJun 10, 2025Break; Break

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

  Patient problems: Insufficient Information

  MAUDE report 22179540 ↗
• MalfunctionApr 1, 2025Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE DISCONNECTED AFTER THE CLOSED SUCTION CATHETER WAS CHANGED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21740312 ↗
• MalfunctionMar 24, 2025Break; Break

  IT WAS REPORTED, AFTER INTUBATION, A CLOSED SUCTION CATHETER WAS ATTACHED TO THE PATIENT; DURING A ROUND, THE NURSE NOTICED THE 'TRACK CARE' FLAPPER HAD FALLEN OFF AND RETRIEVED IT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678965 ↗
• MalfunctionMar 20, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE PATIENT (WITH AN UNSPECIFIED EXISTING INFECTION) WAS INTUBATED ON (B)(6) 2025, THE FLAPPER VALVE WAS OBSERVED IN THE FLEX TUBE SECTION THE FOLLOWING DAY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21656603 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED, BEFORE SUCTION WAS PERFORMED, THE TRACK CARE WAS REPLACED AFTER NOTICING AN UNUSUAL LACK OF CATE RESISTANCE. UPON CHECKING INSIDE THE TRACK CARE, THE FLAPPER VALVE WAS MISSING. AFTER SEARCHING THE AREA, IT WAS FOUND ATTACHED TO THE PATIENT'S NECK (OUTSIDE THE BODY). THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047940 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE WAS DAMAGED AND IT WAS CAUGHT BEFORE IT WENT INTO THE TRACHEAL TUBE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028683 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED, THE FLAPPER VALVE FELL OFF DURING PATIENT USE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21028535 ↗
• MalfunctionDec 10, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE FLAPPER VALVE STAYS OPEN DURING USE. (IT DOES NOT CLOSE) THE PATIENT USES IT WITHOUT ANY PROBLEM UNTIL THE PREPARATION BEFORE WEARING IT AND FOR ABOUT 24 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897867 ↗
• MalfunctionNov 8, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED, THE FLEX CONNECTOR WAS LOOSE AND SEEMED TO COME OFF 'SOON'; THE FLEX CONNECTOR HAD BEEN IN USE FOR TWO DAYS. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20644809 ↗
• MalfunctionJul 12, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED, THE CLOSED SUCTION CATHETER (CSC) WAS REPLACED ON (B)(6) 2024; THE SLEEVE WAS FOUND TO BE SWOLLEN THE FOLLOWING DAY. THIS DID NOT OCCUR DURING SUCTIONING; THE CSC WAS REPLACED, THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19729370 ↗
• MalfunctionJul 1, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE DEVICE HAD BEEN IN PLACE FROM (B)(6) TO THE (B)(6), (IT WAS THE 3RD USE [OF DEVICE]). WHEN REPLACING THE CLOSED SUCTION CATHETER (CSC), THE FLAPPER VALVE WAS FOUND IN[SIDE] THE FLEX CONNECTOR. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19651213 ↗
• MalfunctionJun 24, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, FLAPPER VALVE CAME OFF; IT WAS FOUND [TO BE MISSING] WHEN THE CATHETER WAS BEING REPLACED. AN XRAY WAS USED TO CONFIRM NO RETAINED PIECES WERE FOUND IN THE PATIENT, THE LOCATION OF THE VALVE IS UNKNOWN. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19594529 ↗
• MalfunctionJun 18, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED, THE SLEEVE INFLATED AFTER SUCTIONING. THE DEVICE WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19557687 ↗
• MalfunctionMay 20, 2024Material Integrity Problem; Material Integrity Problem

  PER GOOGLE TRANSLATE: IT WAS REPORTED, THE IRRIGATION PORT BROKE, NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED 02MAY2024 REPORTED, (PER GOOGLE TRANSLATE): THE DEVICE WAS ESTABLISHED ON THE PATIENT ON (B)(6) 2024, ON (B)(6) 2024, A CLINICAL ENGINEER (WHO WAS PERFORMING ROUNDS) DISCOVERED A BROKEN VALVE IN ONE OF THE TRACK CARES; THE FLAPPER VALVE WAS TORN OFF AND FELL ON THE CATHETER MOUNT SIDE. IT WAS ADDITIONALLY REPORTED, PRIOR TO THE INCIDENT, THE STAFF HAD BEEN ABLE TO PERFORM SUCTION AND CATHETER CLEANING WITHOUT ANY PROBLEMS, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350665 ↗
• MalfunctionMay 13, 2024Inflation Problem; Inflation Problem

  AVANOS MEDICAL INC. 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 8030647-2024-00037 FOR THE FIRST REPORT IT WAS REPORTED, THE SLEEVE INFLATED, AFTER ASPIRATION (NOT DURING SUCTIONING). THE USER WAS CAREFUL TO STOP EXTRACTING THE CATHETER WHEN THE BLACK MARKER WAS SEEN; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19299798 ↗
• MalfunctionMay 13, 2024Inflation Problem; Inflation Problem

  AVANOS MEDICAL INC. 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 8030647-2024-00038 FOR THE SECOND REPORT. IT WAS REPORTED, THE SLEEVE INFLATED, AFTER ASPIRATION (NOT DURING SUCTIONING). THE USER WAS CAREFUL TO STOP EXTRACTING THE CATHETER WHEN THE BLACK MARKER WAS SEEN; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19299739 ↗
• MalfunctionFeb 27, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, THE LEAK ALARM SOUNDED ON THE RESPIRATOR, DURING USE, IT WAS CONFIRMED THE SUCTION CATHETER WAS CONNECTED PROPERLY; AFTER THE CATHETER WAS REPLACED THERE WAS NO PROBLEM. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18788320 ↗
• MalfunctionFeb 20, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED, THE SLEEVE INFLATED DURING SUCTIONING; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18738180 ↗
• MalfunctionFeb 13, 2024Leak/Splash; Leak/Splash

  AVANOS MEDICAL INC. 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 8030647-2024-00006 FOR THE FIRST REPORT. IT WAS REPORTED, THE DEVICE WAS REPLACED, (THE PROCEDURE WAS THE SAME AS USUAL), BUT FOR SOME REASON IT [THE CLOSED SUCTION CATHETER (CSC)] LEAKED, "BY NOT PULLING OUT TOO MUCH"; THE DEVICE WAS REPLACED, AND THE ISSUE RESOLVED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 07FEB2024 REPORTED, THE DEVICE HAD BEEN IN PLACE FOR 24-48 HOURS, THE LOCATION OF THE LEAK WAS NOTED TO BE, "CONFIRMED BUT NOT SURE". THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696004 ↗
• MalfunctionFeb 13, 2024Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. 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 8030647-2024-00007 FOR THE SECOND REPORT. IT WAS REPORTED, THE PROCEDURE WAS THE SAME AS USUAL, BUT FOR SOME REASON IT [THE CLOSED SUCTION CATHETER (CSC)] LEAKED, "BY NOT PULLING OUT TOO MUCH"; THE DEVICE WAS REPLACED. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 07FEB2024 REPORTED, THE DEVICE HAD BEEN IN PLACE FOR 24-48 HOURS, THE LOCATION OF THE LEAK WAS NOTED TO BE, "CONFIRMED BUT NOT SURE". THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695991 ↗
• MalfunctionSep 26, 2023Backflow; Backflow

  IT WAS REPORTED, THE SLEEVE INFLATED DURING SUCTIONING; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17821918 ↗
• MalfunctionSep 12, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED, THE SUCTION CATHETER WAS "ATTACHED" TO THE PATIENT AT 6PM AND AT 10PM A LEAK OCCURRED DURING SUCTIONING (IN THE THUMB VALVE).

  Patient problems: Insufficient Information

  MAUDE report 17729695 ↗