Ballard* Closed Suction System for Adults 93907Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00609038939070), received between Dec 18, 2020 and Jun 20, 2025 — classified as 1 injury, 28 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (15 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED, THE ELBOW BROKE OFF DURING USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302991 ↗
• InjuryMay 12, 2023Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED "WHILE CARING FOR A PATIENT WITH A TRACHEOSTOMY, 2210 [MEDICAL DEVICE] WAS ATTACHED INSTEAD OF THE INTENDED 22103 [MEDICAL DEVICE]. [THE NURSE] STATES SHE LOOKED AT THE IFU [INSTRUCTIONS FOR USE] FOR THE 2210 [MEDICAL DEVICE] AND NOTED THAT IT SPECIFICALLY STATES NOT TO USE ON TRACHEOSTOMY PATIENTS, BUT SHE NOTED THAT IT WAS NOT ON OUTSIDE PACKAGING. SHE STATES THAT SHE NOTED ON PACKAGING FOR 22103 [MEDICAL DEVICE], IT STATES TO USE ONLY ON TRACHEOSTOMY PATIENTS. PATIENT DEVELOPED BLOODY SECRETIONS AS A RESULT OF BEING SUCTIONED WITH 2210 [MEDICAL DEVICE]. A BRONCHOSCOPY WAS DONE TO DETERMINE CAUSE FOR BLOODY SECRETIONS, AND THAT IS WHEN IT WAS NOTED THAT THE CLOSED SUCTION TUBING WAS ENDOTRACHEAL TUBE LENGTH, NOT TRACHEOSTOMY LENGTH. STATES THAT TRACHEAL TRAUMA CAUSED THE SECRETIONS AS A RESULT OF THE 2210[MEDICAL DEVICE]. THEY REMOVED THE 2210 [MEDICAL DEVICE] AND REPLACED WITH 22103 [MEDICAL DEVICE]."

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16924497 ↗
• MalfunctionAug 29, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THE SUCTION CATHETER WOULD NOT ENGAGE WHEN THE BUTTON WAS PRESSED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15317276 ↗
• MalfunctionApr 13, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2022-00113 FOR THE FIRST REPORT REFER TO 8030647-2022-00114 FOR THE SECOND REPORT IT WAS REPORTED THAT THE SUCTION BUTTON ON THE CLOSED SUCTION CATHETER (CSC) WAS DIFFICULT TO PRESS AND ONCE PRESSED, THE CSC SUCTION DID NOT ACTIVATE. THE CSC WAS REPLACED WITH ANOTHER SUCTION CATHETER AND THE ISSUE RESOLVED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107016 ↗
• MalfunctionApr 13, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2022-00113 FOR THE FIRST REPORT. REFER TO 8030647-2022-00115 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE SUCTION BUTTON ON THE CLOSED SUCTION CATHETER (CSC) WAS DIFFICULT TO PRESS AND ONCE PRESSED, THE CSC SUCTION DID NOT ACTIVATE. THE CSC WAS REPLACED WITH ANOTHER SUCTION CATHETER AND THE ISSUE RESOLVED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107013 ↗
• MalfunctionApr 13, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00114 FOR THE SECOND REPORT. REFER TO 8030647-2022-00115 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE SUCTION BUTTON ON THE CLOSED SUCTION CATHETER (CSC) WAS DIFFICULT TO PRESS AND ONCE PRESSED, THE CSC SUCTION DID NOT ACTIVATE. THE CSC WAS REPLACED WITH ANOTHER SUCTION CATHETER AND THE ISSUE RESOLVED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107010 ↗
• MalfunctionMar 31, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2022-00104 FOR THE FIRST EVENT. REFER TO 8030647-2022-00105 FOR THE SECOND EVENT. IT WAS REPORTED THE SUCTION CATHETER WASN'T WORKING PROPERLY. THE SUCTION CATHETER BUTTON WAS PRESSED BUT THE SUCTION CATHETER DIDN'T SUCTION. THE DEVICE WAS REPLACED FOR A NEW DEVICE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13960920 ↗
• MalfunctionMar 30, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2022-00104 FOR THE FIRST EVENT. REFER TO 8030647-2022-00106 FOR THE THIRD EVENT. IT WAS REPORTED AFTER A PATIENT WAS INTUBATED, THE CLOSED SUCTION CATHETER WAS PLACED AND CLINICIAN ATTEMPTED TO SUCTION THE PATIENT. THE CLINICIAN ADVANCED THE SUCTION CATHETER AND PRESSED THE SUCTION BUTTON, BUT THE SUCTION CATHETER DID NOT SUCTION. THE DEVICE WAS REPLACED FOR A NEW DEVICE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945848 ↗
• MalfunctionMar 29, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00105 FOR THE SECOND EVENT. REFER TO 8030647-2022-00106 FOR THE THIRD EVENT. IT WAS REPORTED AFTER A PATIENT WAS INTUBATED, THE CLOSED SUCTION CATHETER WAS PLACED AND CLINICIAN ATTEMPTED TO SUCTION THE PATIENT. THE CLINICIAN ADVANCED THE SUCTION CATHETER AND PRESSED THE SUCTION BUTTON, BUT THE SUCTION CATHETER DID NOT SUCTION. THE DEVICE WAS REPLACED FOR A NEW DEVICE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13942827 ↗
• MalfunctionMar 16, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00090 FOR THE FIRST REPORT. THE CLINICIAN REPORTED THAT WE HAVE AN ADULT CATHETER THAT IS NOT WORKING, THE BUTTON DOES NOT CREATE SUCTION WHEN PRESSED; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 21FEB2022, REPORTED THAT THE SUCTION ISSUE WAS DISCOVERED DURING USE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777207 ↗
• MalfunctionMar 16, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00091 FOR THE SECOND REPORT. THE CLINICIAN REPORTED THAT WE HAVE AN ADULT CATHETER THAT IS NOT WORKING, THE BUTTON DOES NOT CREATE SUCTION WHEN PRESSED; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 21FEB2022, REPORTED THAT THE SUCTION ISSUE WAS DISCOVERED DURING USE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777200 ↗
• MalfunctionMar 4, 2022Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00082 FOR THE FIRST EVENT. IT WAS REPORTED DURING INITIAL USE THE "AIRWAY CONNECTION [WAS] SNAPPING OFF IN HALF AT STEM." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13668175 ↗
• MalfunctionMar 4, 2022Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00086 FOR THE SECOND EVENT. IT WAS REPORTED DURING INITIAL USE THE "AIRWAY CONNECTION [WAS] SNAPPING OFF IN HALF AT STEM." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13668133 ↗
• MalfunctionMar 2, 2022Suction Problem; Suction 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 8030647-2022-00080 FOR THE FIRST REPORT. IT WAS REPORTED BY THE INTENSIVE CARE UNIT (ICU) RESPIRATORY THERAPIST (RT) THAT WHEN THE WHITE BUTTON WAS PRESSED ENTIRELY THEY WERE GETTING MINIMAL, IF ANY, SUCTION WHILE USING THE ET CLOSED SUCTION CATHETER (CSC). THERE WAS NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655598 ↗
• MalfunctionMar 2, 2022Suction Problem; Suction 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 8030647-2022-00081 FOR THE SECOND REPORT. IT WAS REPORTED BY THE INTENSIVE CARE UNIT (ICU) RESPIRATORY THERAPIST (RT) THAT WHEN THE WHITE BUTTON WAS PRESSED ENTIRELY THEY WERE GETTING MINIMAL, IF ANY, SUCTION WHILE USING THE ET CLOSED SUCTION CATHETER (CSC). THERE WAS NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655575 ↗
• MalfunctionFeb 26, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THE CLOSED SUCTION CATHETER WAS NOT WORKING AS WELL. THE "BUTTON" DOES NOT CREATE SUCTION WHEN PRESSED. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13609156 ↗
• MalfunctionFeb 21, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00055 FOR THE FIRST EVENT. IT WAS REPORTED THE CLOSED SUCTION CLOSED SUCTION CATHETER WOULD NOT SUCTION. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13573258 ↗
• MalfunctionFeb 21, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00056 FOR THE SECOND EVENT. IT WAS REPORTED THE CLOSED SUCTION CLOSED SUCTION CATHETER WOULD NOT SUCTION. THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13572939 ↗
• MalfunctionFeb 18, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2022-00061 FOR THE FIRST REPORT, REFER TO 8030647-2022-00062 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED [TO SUCTION DURING USE. THE CSC WAS REPLACED WITH A NEW ONE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564499 ↗
• MalfunctionFeb 18, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 8030647-2022-00061 FOR THE FIRST REPORT. REFER TO 8030647-2022-00063 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION DURING USE. THE CSC WAS REPLACED WITH A NEW ONE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564498 ↗
• MalfunctionFeb 18, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 8030647-2022-00062 FOR THE SECOND REPORT. REFER TO 8030647-2022-00063 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER (CSC) FAILED TO SUCTION DURING USE. THE CSC WAS REPLACED WITH A NEW ONE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13564497 ↗
• MalfunctionFeb 15, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE IN-LINE SUCTION WAS NOT SUCTIONING, ON THE CLOSED SUCTION CATHETER (CSC) DURING USE; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 14FEB2022 REPORTED THE INCIDENT OCCURRED DURING THE INITIAL USE/PLACEMENT OF THE CSC ON THE PATIENT, AND THE CSC WAS IMMEDIATELY REPLACED FOR A NEW ONE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13535623 ↗
• MalfunctionFeb 4, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 8030647-2022-00022 FOR THE FIRST EVENT. REFER TO 8030647-2022-00024 FOR THE THIRD EVENT. REFER TO 8030647-2022-00025 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00029 FOR THE FIFTH EVENT. IT WAS REPORTED THE CLOSED SUCTION CATHETER WOULD NOT SUCTION. THE HEALTHCARE PROFESSIONAL WAS ¿UNABLE TO SUCTION THROUGH THE TRACH SITE."

  Patient problems: Insufficient Information

  MAUDE report 13453933 ↗
• MalfunctionFeb 2, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 8030647-2022-00023 FOR THE SECOND EVENT. REFER TO 8030647-2022-00024 FOR THE THIRD EVENT. REFER TO 8030647-2022-00025 FOR THE FOURTH EVENT. REFER TO 8030647-2022-00029 FOR THE FIFTH EVENT. IT WAS REPORTED THE CLOSED SUCTION CATHETER WOULD NOT SUCTION. THE HEALTHCARE PROFESSIONAL WAS ¿UNABLE TO SUCTION THROUGH THE TRACH SITE." THE HEALTHCARE PROFESSION CHECKED THE SUCTION CANNISTER AND THE ORAL SUCTION AND BOTH WERE "WORKING FINE." THE HEALTHCARE PROFESSIONAL MANUALLY SUCTIONED THE PATIENT WITH A 14 FRENCH CATHETER AND IT WORKED WELL. AFTER TRYING EVERYTHING, THE HEALTHCARE PROFESSIONAL RECHECKED IN-LINE SUCTION CATHETER. ALL THIS TIME THE PATIENT WAS COUGHING FORCEFULLY AND THE OXYGEN SATURATION LEVEL WAS LOW. THE HEALTHCARE PROFESSION CHANGED THE IN-LINE SUCTION CATHETER AGAIN AND IT FINALLY WORKED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13430158 ↗
• MalfunctionFeb 2, 2022Suction Failure; Suction Failure

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT EVENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 8030647-2022-00022 FOR THE FIRST EVENT. REFER TO 8030647-2022-00023 FOR THE SECOND EVENT. REFER TO 8030647-2022-00024 FOR THE THIRD EVENT. REFER TO 8030647-2022-00029 FOR THE FIFTH EVENT. IT WAS REPORTED THE CLOSED SUCTION CATHETER WOULD NOT SUCTION. THE HEALTHCARE PROFESSIONAL WAS ¿UNABLE TO SUCTION THROUGH THE TRACH SITE."

  Patient problems: Insufficient Information

  MAUDE report 13430152 ↗