Ballard* Closed Suction System 98386Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00609038983868), received between Jun 19, 2020 and Nov 5, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Backflow” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Material Puncture/Hole; Material Puncture/Hole

  SUNMED HOLDINGS LLC. 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 8030647-2025-00121 FOR THE SECOND REPORT IT WAS REPORTED: WHEN INSERTING AN 8FR BALLARD CLOSED-CIRCUIT CATHETER, IT WAS DETECTED THAT IT WAS PIERCED, MAKING IT IMPOSSIBLE TO USE ON THE PATIENT. THERE WAS NO REPORTED INJURY AS A RESULT OF THIS REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482421 ↗
• MalfunctionNov 5, 2025Material Puncture/Hole; Material Puncture/Hole

  SUNMED HOLDINGS LLC. 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 8030647-2025-00120 FOR THE FIRST REPORT. IT WAS REPORTED: WHEN INSERTING AN 8FR BALLARD CLOSED-CIRCUIT CATHETER, IT WAS DETECTED THAT IT WAS PIERCED, MAKING IT IMPOSSIBLE TO USE ON THE PATIENT. THERE WAS NO REPORTED INJURY AS A RESULT OF THIS REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23482420 ↗
• MalfunctionSep 25, 2025Gas/Air Leak; Gas/Air Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00089 FOR THE SECOND REPORT. IT WAS REPORTED: THE PATIENT WAS STABLE ON MECHANICAL VENTILATION AND THE INLINE SUCTION CATHETER WAS DUE FOR THE ROUTINE/DAILY CHANGE. UPON CHANGING TO THE AVANOS INLINE SUCTION CATHETER, THE PLASTIC COVER BALLOONED, AND THE VENTILATOR LEAK INCREASED; TROUBLESHOOTING WAS PERFORMED; HOWEVER IT FAILED TO RESOLVE THE ISSUE, THE CLOSED SUCTION CATHETER WAS REPLACED. NO CHANGES WERE NOTED IN THE PATIENT'S VITAL SIGNS OR OVERALL CLINICAL CONDITION DURING OR AFTER THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151357 ↗
• MalfunctionSep 25, 2025Leak/Splash; Leak/Splash

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2025-00088 FOR THE FIRST REPORT. IT WAS REPORTED, THE REPLACEMENT SUCTION CATHETER WAS IMMEDIATELY REMOVED AND WAS REPLACED WITH A CATHETER FROM A DIFFERENT BRAND, WHICH RESOLVED THE ISSUE. NO CHANGES WERE NOTED IN THE PATIENT'S VITAL SIGNS OR OVERALL CLINICAL CONDITION DURING OR AFTER THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23151355 ↗
• MalfunctionJul 17, 2025Gas/Air Leak; Gas/Air Leak

  THE CAREGIVER REPORTED, THE CLOSED SUCTION CATHETER (CSC) WAS CHANGED; NO ISSUE WAS NOTED. ADDITIONAL CARE(S) OF THE PATIENT WERE PERFORMED AND THEY WERE REPOSITIONED, AFTER WHICH A LEAK ON THE VENTILATOR WAS NOTED TO HAVE INCREASED AND THE CSC BALLOONED. THE CAREGIVER, ATTEMPTED TO HOLD THE CCS SO THAT IT WOULD NOT GET ANYMORE AIR AND THE LEAK WENT DOWN. THE CSC WAS IMMEDIATELY REMOVED AND THE TECHNICIAN SPECIALIST WAS INFORMED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22537511 ↗
• MalfunctionJul 17, 2024Backflow; Backflow

  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 8030647-2024-00059 FOR THE FIRST REPORT. IT WAS REPORTED, THE SLEEVE [ON THE CLOSED SUCTION CATHETER (CSC)] EXPANDED, AFTER BEING PLACED; THE CSC WAS REMOVED; THERE WERE NO REPORTED INJURIES. ADDITIONAL INFORMATION RECEIVED 22JUN2024 REPORTED, THE CSC EXPANDED, IMMEDIATELY UPON CHANGING TO A NEW INLINE SUCTION CATHETER; THERE WERE NO REPORTED INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767743 ↗
• MalfunctionJul 17, 2024Backflow; Backflow

  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 8030647-2024-00060 FOR THE SECOND REPORT IT WAS REPORTED, THE SLEEVE [ON THE CLOSED SUCTION CATHETER (CSC)] EXPANDED, AFTER BEING PLACED; THE CSC WAS REMOVED; THERE WERE NO REPORTED INJURIES. ADDITIONAL INFORMATION RECEIVED 22JUN2024 REPORTED, THE CSC EXPANDED, IMMEDIATELY UPON CHANGING TO A NEW INLINE SUCTION CATHETER; THERE WERE NO REPORTED INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767741 ↗
• MalfunctionSep 25, 2020Retraction Problem; Retraction Problem

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

  Patient problems: Respiratory Distress

  MAUDE report 10586579 ↗
• MalfunctionJun 19, 2020Break; Break

  IT WAS REPORTED THAT THE "Y-ADAPTER BROKE OFF BECAUSE OF WHICH THE VENTILATION TUBE CAME OFF." NO PATIENT INJURY WAS REPORTED. IMAGES OF THE DEVICE WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10174793 ↗