Ballard* Closed Suction System 98388Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00609038983882), received between Oct 24, 2024 and Oct 24, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Gas/Air Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 24, 2024Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. 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 8030647-2024-00076 FOR THE FIRST REPORT. A MEMBER OF THE NURSING TEAM REPORTED, DURING THE NIGHT SHIFT, A ROUTINE CLOSE SUCTION CHANGE [WAS] UNDERTAKEN USING BALLARD CLOSED SUCTION (ELBOW) SIZE 6FR FOR THE FIRST TIME AND THE BABY¿S TRANSCUTANEOUS PARTIAL PRESSURE OF CO2 (TCPCO2) INCREASED CONSIDERABLY WITH EPISODES OF DESATURATION AND REQUIRED INCREASED OXYGEN. DURING [THE] DAY SHIFT A NEW BALLARD CLOSED SUCTION (ELBOW) SIZE 6FR WAS TRAILED AGAIN ON THE SAME BABY, AND IT WAS NOTED A SUDDEN DRASTIC INCREASE [OF] TCPCO2 AND DESATURATION; [THE] BABY [AGAIN] REQUIRED AN INCREASE IN OXYGEN. THE DECISION WAS MADE TO DO A CAPILLARY BLOOD GAS WHICH SHOWED A CORRELATION IN THE INCREASE OF THE PC02 [THE] BABY REQUIRED AND INCREASE IN VENTILATION PRESSURES. ON REVIEW OF [THE] BLOOD GAS THE BALLARD CLOSED SUCTION (ELBOW) SIZE 6FR WAS REMOVED AND A AN 8 FR BALLARD CLOSED SUCTION (Y-ADAPTER) WAS ATTACHED; [THE] BABY¿S TCPCO2 READING STABILIZED, AND A BLOOD GAS WAS REPEATED WHICH REFLECTED THE IMPR

  Patient problems: Low Oxygen Saturation

  MAUDE report 20529695 ↗
• InjuryOct 24, 2024Gas/Air Leak; Gas/Air Leak

  AVANOS MEDICAL INC. 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 8030647-2024-00077 FOR THE SECOND REPORT. A MEMBER OF THE NURSING TEAM REPORTED, DURING THE NIGHT SHIFT, A ROUTINE CLOSE SUCTION CHANGE [WAS] UNDERTAKEN USING BALLARD CLOSED SUCTION (ELBOW) SIZE 6FR FOR THE FIRST TIME AND THE BABY¿S TRANSCUTANEOUS PARTIAL PRESSURE OF CO2 (TCPCO2) INCREASED CONSIDERABLY WITH EPISODES OF DESATURATION AND REQUIRED INCREASED OXYGEN. DURING [THE] DAY SHIFT A NEW BALLARD CLOSED SUCTION (ELBOW) SIZE 6FR WAS TRAILED AGAIN ON THE SAME BABY, AND IT WAS NOTED A SUDDEN DRASTIC INCREASE [OF] TCPCO2 AND DESATURATION; [THE] BABY [AGAIN] REQUIRED AN INCREASE IN OXYGEN. THE DECISION WAS MADE TO DO A CAPILLARY BLOOD GAS WHICH SHOWED A CORRELATION IN THE INCREASE OF THE PC02 [THE] BABY REQUIRED AND INCREASE IN VENTILATION PRESSURES. ON REVIEW OF [THE] BLOOD GAS THE BALLARD CLOSED SUCTION (ELBOW) SIZE 6FR WAS REMOVED AND A AN 8 FR BALLARD CLOSED SUCTION (Y-ADAPTER) WAS ATTACHED; [THE] BABY¿S TCPCO2 READING STABILIZED, AND A BLOOD GAS WAS REPEATED WHICH REFLECTED THE IMPR

  Patient problems: Low Oxygen Saturation

  MAUDE report 20527869 ↗