Ballard* Turbo-Cleaning Closed Suction System 92481Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00609038924816), received between Apr 14, 2022 and Feb 19, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Suction Problem” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2025Increase in Suction; Increase in Suction

  SUNMED HOLDINGS LLC. 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 8030647-2025-00017 FOR THE SECOND REPORT. REFER TO 8030647-2025-00018 FOR THE THIRD REPORT. IT WAS REPORTED, WHEN THE SUCTION ACTIVATION BUTTON WAS PRESSED TO APPLY SUCTION, IT REMAINED PRESSED, RESULTING IN CONTINUOUS SUCTION; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21413013 ↗
• MalfunctionFeb 19, 2025Increase in Suction; Increase in Suction

  SUNMED HOLDINGS LLC. 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 8030647-2025-00016 FOR THE FIRST REPORT. REFER TO 8030647-2025-00017 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN THE SUCTION ACTIVATION BUTTON WAS PRESSED TO APPLY SUCTION, IT REMAINED PRESSED, RESULTING IN CONTINUOUS SUCTION; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21412996 ↗
• MalfunctionFeb 19, 2025Increase in Suction; Increase in Suction

  SUNMED HOLDINGS LLC. 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 8030647-2025-00016 FOR THE FIRST REPORT. REFER TO 8030647-2025-00018 FOR THE THIRD REPORT. IT WAS REPORTED, WHEN THE SUCTION ACTIVATION BUTTON WAS PRESSED TO APPLY SUCTION, IT REMAINED PRESSED, RESULTING IN CONTINUOUS SUCTION; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21412992 ↗
• MalfunctionApr 14, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 8030647-2022-00116 FOR THE FIRST REPORT. REFER TO 8030647-2022-00117 FOR THE SECOND REPORT. REFER TO 8030647-2022-00118 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE IN-LINE SUCTION CATHETER WAS NOT APPLYING VACUUM WHEN THE SUCTION BUTTON WAS PRESSED; IT APPEARED THAT THE HOLE IN THE BUTTON TO ALLOW VACUUM TO BE GENERATED WAS NOT THERE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 23MAR2022 REPORTED, THAT THE CATHETER WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 14115934 ↗
• MalfunctionApr 14, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 8030647-2022-00116 FOR THE FIRST REPORT. REFER TO 8030647-2022-00118 FOR THE THIRD REPORT. REFER TO 8030647-2022-00119 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE IN-LINE SUCTION CATHETER WAS NOT APPLYING VACUUM WHEN THE SUCTION BUTTON WAS PRESSED; IT APPEARED THAT THE HOLE IN THE BUTTON TO ALLOW VACUUM TO BE GENERATED WAS NOT THERE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 23MAR2022 REPORTED, THAT THE CATHETER WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 14115933 ↗
• MalfunctionApr 14, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 8030647-2022-00117 FOR THE SECOND REPORT. REFER TO 8030647-2022-00118 FOR THE THIRD REPORT. REFER TO 8030647-2022-00119 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE IN-LINE SUCTION CATHETER WAS NOT APPLYING VACUUM WHEN THE SUCTION BUTTON WAS PRESSED; IT APPEARED THAT THE HOLE IN THE BUTTON TO ALLOW VACUUM TO BE GENERATED WAS NOT THERE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 23MAR2022 REPORTED, THAT THE CATHETER WAS REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 14115923 ↗
• InjuryApr 14, 2022Suction Problem; Suction Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 8030647-2022-00116 FOR THE FIRST REPORT. REFER TO 8030647-2022-00117 FOR THE SECOND REPORT. REFER TO 8030647-2022-00119 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE IN-LINE SUCTION CATHETER WAS NOT APPLYING VACUUM WHEN THE SUCTION BUTTON WAS PRESSED; IT APPEARED THAT THE HOLE IN THE BUTTON TO ALLOW VACUUM TO BE GENERATED WAS NOT THERE. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED ON 23MAR2022 REPORTED, THAT THE CATHETER WAS REPLACED. ADDITIONALLY, IT WAS REPORTED THAT AN UNSPECIFIED ADVERSE EVENT OCCURRED; HOWEVER, NO MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 14115915 ↗