Ballard* Turbo-Cleaning Closed Suction System 98965Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00609038989655), received between Sep 2, 2020 and Sep 16, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Material Too Soft/Flexible” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 19, 2025Class IOpen, Classified

   Lack of sterility assurance for closed suction catheter systems

   Z-1527-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Material Integrity Problem

  Patient problems: Insufficient Information

  MAUDE report 50795032 ↗
• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED, THE CLOSED SUCTION CATHETER SNAPPED (AT THE PATIENT END) DURING USE; THE DEVICE WAS REPLACED FOR A NEW ONE; THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21072943 ↗
• MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 8030647-2024-00064 FOR THE FIRST REPORT. REFER TO 8030647-2024-00065 FOR THE SECOND REPORT. REFER TO 8030647-2024-00066 FOR THE THIRD REPORT. REFER TO 8030647-2024-00067 FOR THE FOURTH REPORT . IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990752 ↗
• MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 8030647-2024-00064 FOR THE FIRST REPORT. REFER TO 8030647-2024-00065 FOR THE SECOND REPORT. REFER TO 8030647-2024-00066 FOR THE THIRD REPORT. REFER TO 8030647-2024-00068 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990750 ↗
• MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 8030647-2024-00064 FOR THE FIRST REPORT. REFER TO 8030647-2024-00065 FOR THE SECOND REPORT. REFER TO 8030647-2024-00067 FOR THE FOURTH REPORT. REFER TO 8030647-2024-00068 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990748 ↗
• MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 8030647-2024-00065 FOR THE SECOND REPORT. REFER TO 8030647-2024-00066 FOR THE THIRD REPORT. REFER TO 8030647-2024-00067 FOR THE FOURTH REPORT. REFER TO 8030647-2024-00068 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990736 ↗
• MalfunctionAug 15, 2024Material Too Soft/Flexible; Material Too Soft/Flexible

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 8030647-2024-00064 FOR THE FIRST REPORT. REFER TO 8030647-2024-00066 FOR THE THIRD REPORT. REFER TO 8030647-2024-00067 FOR THE FOURTH REPORT . REFER TO 8030647-2024-00068 FOR THE FIFTH REPORT. IT WAS REPORTED, WHEN THE CATHETER WAS ADVANCED INTO THE ENDOTRACHEAL TUBE / TRACHEOSTOMY TUBE (ETT) [THE] CONNECTOR DIPPED AND CAUGHT ONTO THE CONNECTOR AND THE CLINICIAN WAS NOT ABLE TO PASS THE CATHETER DOWN INTO THE AIRWAY FOR EFFECTIVE SUCTIONING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990734 ↗
• MalfunctionAug 5, 2024Suction Failure; Suction Failure

  IT WAS REPORTED, THE DEVICE DID NOT SUCTION, THERE WAS A DELAY IN SUCTIONING THE PATIENT; HOWEVER, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911608 ↗
• MalfunctionMar 25, 2024Misassembled; Misassembled

  IT WAS REPORTED, THAT WHILE ATTEMPTING TO SUCTION A PATIENT, A SMALL EXTRA PORT ON THE CONNECTION TO PATIENT WAS NOTED AND THEY WERE UNABLE TO USE SUCTION. IT WAS ADDITIONALLY REPORTED, THE STAFF MEMBER PLACED A GLOVED FINGER OVER THE EXTRA PORT, WHILE A NEW SET WAS SOURCED. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968611 ↗
• MalfunctionJul 14, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, ¿THUMB VALVE OF CLOSE SUCTION CATHETER DIDN¿T WORK DURING SUCTIONING PROCESS.¿ THE PATIENT WAS REPORTED TO BE FINE; NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17324273 ↗
• MalfunctionJun 26, 2023Suction 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 8030647-2023-00096 FOR THE FIRST REPORT. IT WAS REPORTED, THE CLOSED SUCTION CATHETER (CSC) DID NOT CLEAR THICK SECRETIONS; THE PATIENT WAS REPORTEDLY FINE AFTER.

  Patient problems: Insufficient Information

  MAUDE report 17204730 ↗
• MalfunctionJun 26, 2023Suction 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 (B)(4) FOR THE SECOND REPORT. IT WAS REPORTED, THE CLOSED SUCTION CATHETER (CSC) DID NOT CLEAR THICK SECRETIONS; THE PATIENT WAS REPORTEDLY FINE AFTER.

  Patient problems: Insufficient Information

  MAUDE report 17204712 ↗
• MalfunctionMar 8, 2023Ejection Problem; Ejection Problem

  IT WAS REPORTED, THE LOCKING SYSTEM ON THE THUMB VALVE GOT STUCK (DOWN) IN THE SUCTION MODE AND THE BUTTON HAD TO BE PULLED OUT MANUALLY. IT WOULDN'T SPRING OUT AS IT SHOULD WHEN LOCKING. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

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

  MAUDE report 16506399 ↗
• MalfunctionNov 21, 2022Break; Break

  IT WAS REPORTED THAT THE CATHETER OF THE CLOSED SUCTION SYSTEM, BROKE OFF OF THE THUMB VALVE. THE CATHETER WAS RETAINED INSIDE OF THE ENDOTRACHEAL TUBE BUT WAS RETRIEVED. THE FACILITY CHANGES THE CLOSED SUCTION CATHETERS EVERY 7 DAYS. THE INCIDENT OCCURRED IN LESS THAN 7 DAYS OF USE HOWEVER EXACT DATE OF PLACEMENT IS UNKNOWN. NO INJURY OR MEDICAL INTERVENTIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15839954 ↗
• InjuryDec 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S STATE OF HEALTH BEGAN TO DETERIORATE. AN ACUTE BRONCHOSCOPY WAS PERFORMED, AND A FOREIGN BODY WAS REMOVED FROM THE LUNGS. THE FOREIGN BODY IS ALLEGED TO BE FROM THE VALVE FLAP OF THE CLOSED SUCTION CATHETER SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Pulmonary Dysfunction

  MAUDE report 10967765 ↗
• MalfunctionSep 2, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE, "TURBO CSC [CLOSED SUCTION CATHETER] SLEEVE BLEW UP WHEN ATTACHED TO THE PT [PATIENT] ON THE VENTILATOR. SUCTION NOT CONNECTED AND CSC [CLOSED SUCTION CATHETER] NOT USED." CLOSED SUCTION CATHETER WAS REPLACED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10483893 ↗