Ballard* Closed Suction System for Adults 93905Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00609038939056), received between Nov 19, 2020 and Mar 20, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2025

  CONNECTED NEW BALLARD TO PATIENT'S TRACH (SWITCHED FROM A SMALLER SIZE); 1 HOUR LATER, ATTEMPTED TO SUCTION PATIENT AND NO SECRETIONS ABLE TO BE SUCTIONED. CHECKED SUCTION TUBING WHICH WAS WORKING. ATTEMPTED TO SUCTION AGAIN UNSUCCESSFULLY. DISCONNECTED BALLARD FROM PATIENT AND NOTICED NOT ABLE TO SUCTION. CHANGED TO A NEW BALLARD AGAIN AND SUCCESSFULLY SUCTIONED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651106 ↗
• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE FIFTH OF SEVEN REPORTS. REFER TO 8030647-2023-00089 FOR THE FIRST REPORT; REFER TO 8030647-2023-00090 FOR THE SECOND REPORT ; REFER TO 8030647-2023-00091 FOR THE THIRD REPORT; REFER TO 8030647-2023-00092 FOR THE FOURTH REPORT ; REFER TO 8030647-2023-00094 FOR THE SIXTH REPORT; REFER TO 8030647-2023-00095 FOR THE SEVENTH REPORT. THE PARENT REPORTED, THE CLOSED SUCTION CATHETER WAS RECEIVED DEFECTIVE (FROM THE DISTRIBUTOR); THE CATHETER WAS STATED TO HAVE FILLED- UP WITH AIR; HOWEVER, THEY WERE NOT ABLE TO SUCTION PATIENT. THERE WAS NO INJURY, AND THE PATIENT IS REPORTEDLY FINE.

  Patient problems: Insufficient Information

  MAUDE report 17121940 ↗
• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE FOURTH OF SEVEN REPORTS. REFER TO 8030647-2023-00089 FOR THE FIRST REPORT; REFER TO 8030647-2023-00090 FOR THE SECOND REPORT; REFER TO 8030647-2023-00091 FOR THE THIRD REPORT; REFER TO 8030647-2023-00093 FOR THE FIFTH REPORT; REFER TO 8030647-2023-00094 FOR THE SIXTH REPORT; REFER TO 8030647-2023-00095 FOR THE SEVENTH REPORT. THE PARENT REPORTED, THE CLOSED SUCTION CATHETER WAS RECEIVED DEFECTIVE (FROM THE DISTRIBUTOR); THE CATHETER WAS STATED TO HAVE FILLED- UP WITH AIR; HOWEVER, THEY WERE NOT ABLE TO SUCTION PATIENT. THERE WAS NO INJURY, AND THE PATIENT IS REPORTEDLY FINE.

  Patient problems: Insufficient Information

  MAUDE report 17121937 ↗
• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE THIRD OF SEVEN REPORTS. REFER TO 8030647-2023-00089 FOR THE FIRST REPORT; REFER TO 8030647-2023-00090 FOR THE SECOND REPORT; REFER TO 8030647-2023-00092 FOR THE FOURTH REPORT; REFER TO 8030647-2023-00093 FOR THE FIFTH REPORT; REFER TO 8030647-2023-00094 FOR THE SIXTH REPORT; REFER TO 8030647-2023-00095 FOR THE SEVENTH REPORT. THE PARENT REPORTED, THE CLOSED SUCTION CATHETER WAS RECEIVED DEFECTIVE (FROM THE DISTRIBUTOR); THE CATHETER WAS STATED TO HAVE FILLED- UP WITH AIR; HOWEVER, THEY WERE NOT ABLE TO SUCTION PATIENT. THERE WAS NO INJURY, AND THE PATIENT IS REPORTEDLY FINE.

  Patient problems: Insufficient Information

  MAUDE report 17121934 ↗
• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE SECOND OF SEVEN REPORTS. REFER TO 8030647-2023-00089 FOR THE FIRST REPORT; REFER TO 8030647-2023-00091 FOR THE THIRD REPORT; REFER TO 8030647-2023-00092 FOR THE FOURTH REPORT; REFER TO 8030647-2023-00093 FOR THE FIFTH REPORT; REFER TO 8030647-2023-00094 FOR THE SIXTH REPORT; REFER TO 8030647-2023-00095 FOR THE SEVENTH REPORT. THE PARENT REPORTED, THE CLOSED SUCTION CATHETER WAS RECEIVED DEFECTIVE (FROM THE DISTRIBUTOR); THE CATHETER WAS STATED TO HAVE FILLED- UP WITH AIR; HOWEVER, THEY WERE NOT ABLE TO SUCTION PATIENT. THERE WAS NO INJURY, AND THE PATIENT IS REPORTEDLY FINE.

  Patient problems: Insufficient Information

  MAUDE report 17121933 ↗
• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE SEVENTH OF SEVEN REPORTS. REFER TO 8030647-2023-00089 FOR THE FIRST REPORT; REFER TO 8030647-2023-00090 FOR THE SECOND REPORT; REFER TO 8030647-2023-00091 FOR THE THIRD REPORT; REFER TO 8030647-2023-00092 FOR THE FOURTH REPORT; REFER TO 8030647-2023-00093 FOR THE FIFTH REPORT; REFER TO 8030647-2023-00094 FOR THE SIXTH REPORT. THE PARENT REPORTED, THE CLOSED SUCTION CATHETER WAS RECEIVED DEFECTIVE (FROM THE DISTRIBUTOR); THE CATHETER WAS STATED TO HAVE FILLED- UP WITH AIR; HOWEVER, THEY WERE NOT ABLE TO SUCTION PATIENT. THERE WAS NO INJURY, AND THE PATIENT IS REPORTEDLY FINE.

  Patient problems: Insufficient Information

  MAUDE report 17121806 ↗
• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE SIXTH OF SEVEN REPORTS. REFER TO 8030647-2023-00089 FOR THE FIRST REPORT; REFER TO 8030647-2023-00090 FOR THE SECOND REPORT; REFER TO 8030647-2023-00091 FOR THE THIRD REPORT; REFER TO 8030647-2023-00092 FOR THE FOURTH REPORT; REFER TO 8030647-2023-00093 FOR THE FIFTH REPORT; REFER TO 8030647-2023-00095 FOR THE SEVENTH REPORT. THE PARENT REPORTED, THE CLOSED SUCTION CATHETER WAS RECEIVED DEFECTIVE (FROM THE DISTRIBUTOR); THE CATHETER WAS STATED TO HAVE FILLED- UP WITH AIR; HOWEVER, THEY WERE NOT ABLE TO SUCTION PATIENT. THERE WAS NO INJURY, AND THE PATIENT IS REPORTEDLY FINE.

  Patient problems: Insufficient Information

  MAUDE report 17121785 ↗
• MalfunctionJun 13, 2023Suction Failure; Suction Failure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SEVEN DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE PATIENT. THIS IS THE FIRST OF SEVEN REPORTS. REFER TO 8030647-2023-00090 FOR THE SECOND REPORT; REFER TO 8030647-2023-00091 FOR THE THIRD REPORT; REFER TO 8030647-2023-00092 FOR THE FOURTH REPORT REFER TO 8030647-2023-00093 FOR THE FIFTH REPORT; REFER TO 8030647-2023-00094 FOR THE SIXTH REPORT; REFER TO 8030647-2023-00095 FOR THE SEVENTH REPORT. THE PARENT REPORTED, THE CLOSED SUCTION CATHETER WAS RECEIVED DEFECTIVE (FROM THE DISTRIBUTOR); THE CATHETER WAS STATED TO HAVE FILLED- UP WITH AIR; HOWEVER, THEY WERE NOT ABLE TO SUCTION PATIENT. THERE WAS NO INJURY, AND THE PATIENT IS REPORTEDLY FINE.

  Patient problems: Insufficient Information

  MAUDE report 17121782 ↗
• MalfunctionJun 9, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER DOES NOT SUCTION. IT IS UNKNOWN WHEN THE PROBLEM WAS NOTICED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098487 ↗
• MalfunctionJun 7, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) DID NOT SUCTION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14622415 ↗
• InjuryNov 19, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTS THAT WHILE SUCTIONING HIMSELF THE CATHETER CAUSED HIM HARM AND HE "BLEED" AND HE EXPERIENCED PAIN IN HIS CHEST. THE PATIENT ALSO SAYS THAT THE DEVICE DOES NOT REACH THE BASE OF THE TRACHEA AND IT GOES ONLY SO FAR; THEREFORE, HE HAS TO PUSH THE CATHETER TO MAKE IT REACH FURTHER, CAUSING HIM TO LOSE AIR, FEEL ASPHYXIA AND HEADACHE. ADDITIONAL INFORMATION RECEIVED 06-NOV-2020 FROM THE PATIENT STATED THE PROBLEM WITH THAT CATHETER IS THE ELBOW SHAPE, IT IS BECAUSE THE BASE WHERE IT CONNECTS TO THE TRACHEOSTOMY IS SMALL. THAT'S WHY THE AIR ESCAPES AND SUFFOCATES [ME] "BECAUSE THE OXYGEN DOES NOT PASS COMPLETELY INTO THE LUNGS THROUGH THAT ESCAPE AND NEITHER DOES IT STAY FIXED IN THE POSITION THAT YOU CONNECT IT, BUT AS TIME GOES BY IT TURNS LITTLE BY LITTLE." ADDITIONALLY, THE ACCORDION SHAPE TUBE CONNECTED ON THE SIDE OF THE CATHETER THAT CONNECTS TO THE SLEEVE OF THE VENTILATOR, THAT SENDS AIR THROUGH THE TRACHEA TOWARDS THE LUNGS, MOVES FROM SIDE TO SIDE.

  Patient problems: Asphyxia; Chest Pain; Headache; No Code Available

  MAUDE report 10870609 ↗