Ballard* Turbo-Cleaning Closed Suction System 98977Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00609038989778), received between May 25, 2021 and Apr 30, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (3 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE END OF THE INLINE SUCTION TUBING SNAPPED OFF WHEN MOVING THE SUCTION LINE, WITH LITTLE TO NO FORCE, WHICH ALLOWED AIR TO ESCAPE THE CIRCUIT. THE TUBE WAS REPORTED TO, "...STILL [BE] IN THE PATIENT AND COULD NOT COLLECT TUBE DUE [TO] THE TUBE STILL FUNCTIONING AS AN ENDOTRACHEAL TUBE." IT WAS ADDITIONALLY REPORTED, "...IT IS UNKNOWN IF THE LINE WAS BITTEN OR IF IT BECAME DETACHED...". THE FAULTY LINE WAS DISCONNECTED FROM THE PATIENT AND A NEW ONE OBTAINED; THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 11APR2024 REPORTED, THE PATIENT¿S CURRENT STATUS AS: EXTUBATED AND DISCHARGED FROM CRITICAL CARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19212714 ↗
• MalfunctionFeb 12, 2024Suction Failure; Suction Failure

  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 8030647-2024-00008 FOR THE FIRST REPORT. IT WAS REPORTED, "THE NEGATIVE PRESSURE COULD NOT BE EXTRACTED"; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18691604 ↗
• MalfunctionFeb 12, 2024Suction Failure; Suction Failure

  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 8030647-2024-00009 FOR THE SECOND REPORT. IT WAS REPORTED, "THE NEGATIVE PRESSURE COULD NOT BE EXTRACTED"; THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18689041 ↗
• MalfunctionAug 29, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, WHEN PERFORMING CLEANING AND FLUSHING, THE SUCTION TUBE CLEANING AND FLUSHING TUBE HOLDER SUDDENLY BROKE, THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17640913 ↗
• MalfunctionJan 9, 2023Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER WAS NOT SUCTIONING. NO VACUUM WAS COMING UP THROUGH THE CIRCUIT. THE PRODUCT WAS IN USE FOR ONE DAY. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 16127463 ↗
• MalfunctionSep 12, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, THE PATIENT¿S INLINE SUCTION BROKE, THE WHITE PLASTIC PART THAT CONNECTED THE TOP BLUE PART OF THE INLINE SUCTION TO THE ENDOTRACHEAL TUBE (ETT) CAME APART AND SEPARATED FROM THE INLINE SUCTION MAKING IT UNUSABLE AND PREVENTED ADEQUATE VENTILATION TO THE PATIENT. THE INLINE SUCTION HAD BEEN CHANGED ON THE DAY SHIFT AND WAS LESS THAN 24 HOURS OLD; THE ETT IN QUESTION WAS IMMEDIATELY REPLACED. NO CHANGES OCCURRED TO THE PATIENT'S SATURATION LEVELS; THERE WAS NO REPORTED INJURY.

  Patient problems: Hypoventilation

  MAUDE report 15401402 ↗
• MalfunctionSep 12, 2022Inflation Problem; Inflation 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 SECOND OF THREE REPORTS. REFER TO 8030647-2022-00195 FOR THE FIRST EVENT. REFER TO 8030647-2022-00197 FOR THE THIRD EVENT. IT WAS REPORTED THE TETHERED SLEEVE CATHETER OVER INFLATED WITH AIR WHILE IN USE ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15401396 ↗
• MalfunctionSep 12, 2022Inflation Problem; Inflation 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 8030647-2022-00196 FOR THE SECOND EVENT. REFER TO 8030647-2022-00197 FOR THE THIRD EVENT. IT WAS REPORTED THE TETHERED SLEEVE CATHETER OVER INFLATED WITH AIR WHILE IN USE ON A PATIENT

  Patient problems: Insufficient Information

  MAUDE report 15401391 ↗
• MalfunctionSep 12, 2022Inflation Problem; Inflation 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 THIRD OF THREE REPORTS. REFER TO 8030647-2022-00195 FOR THE FIRST EVENT. REFER TO 8030647-2022-00196 FOR THE SECOND EVENT. IT WAS REPORTED THE TETHERED SLEEVE CATHETER OVER INFLATED WITH AIR WHILE IN USE ON A PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 15401386 ↗
• MalfunctionJun 24, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  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 8030647-2022-00161 FOR THE FIRST EVENT. REFER TO 8030647-2022-00162 FOR THE SECOND EVENT. IT WAS REPORTED THAT DURING USE OF THE CLOSED SUCTION CATHETER THERE WAS "IN USE TUBE INFLATION" OF THE CATHETER SLEEVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14807496 ↗
• MalfunctionJun 24, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  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 8030647-2022-00162 FOR THE SECOND EVENT. REFER TO 8030647-2022-00163 FOR THE THIRD EVENT. IT WAS REPORTED THAT DURING USE OF THE CLOSED SUCTION CATHETER THERE WAS "IN USE TUBE INFLATION" OF THE CATHETER SLEEVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14807418 ↗
• MalfunctionJun 24, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  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 8030647-2022-00161 FOR THE FIRST EVENT. REFER TO 8030647-2022-00163 FOR THE THIRD EVENT. IT WAS REPORTED THAT DURING USE OF THE CLOSED SUCTION CATHETER THERE WAS "IN USE TUBE INFLATION" OF THE CATHETER SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14807338 ↗
• MalfunctionAug 26, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CATHETER SLEEVE INFLATED DURING USE. NO PATIENT INJURY OR MEDICAL TREATMENT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12371499 ↗
• MalfunctionMay 25, 2021Gas/Air Leak; Failure to Deflate; Gas/Air Leak; Failure to Deflate

  IT WAS REPORTED THAT THE CLOSED SUCTION CATHETER TACTILE SLEEVE REMAINED INFLATED DURING AND AFTER USE. IT WOULD NOT DEFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11877723 ↗