AVANOS 01-EC-459-1401Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00609038000138), received between Mar 31, 2021 and Dec 6, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 6, 2022Decrease in Suction; Decrease in Suction

  THE RESPIRATORY THERAPIST (RT) MANAGER REPORTED, WHILE SUCTIONING WITH THE LIBERATOR CATHETER THEY DID NOT GET MUCH RETURN; THEY REMOVED THE LIBERATOR CLOSED SUCTION CATHETER (CSC) AND REPLACED IT WITH A BALLARD CSC AND REMOVED A LARGE AMOUNT OF SECRETIONS. THE RT MANAGER ADDITIONALLY REPORTED, THAT IN THE PROCESS OF CHANGING THE CATHETER, THE PATIENT STARTED WAKING UP AND COUGHED WHICH MAY HAVE LOOSENED SOME SECRETIONS CAUSING THEM TO BE EASIER TO SUCTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15924402 ↗
• MalfunctionDec 6, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THE "SUCTION POWER SEEMS TO BE AN ISSUE WITH THE SET-UP WE ARE USING." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15922112 ↗
• MalfunctionMar 11, 2022Gas/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 3011270181-2022-00017 FOR THE SECOND REPORT IT WAS REPORTED THAT THE DEVICE MANIFOLD WAS "LEAKY" AND WAS REPLACED. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732101 ↗
• MalfunctionMar 11, 2022Gas/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 3011270181-2022-00016 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE DEVICE MANIFOLD ON THE REPLACEMENT DEVICE WAS ALSO "LEAKY" AND WAS REPLACED AGAIN. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13732090 ↗
• MalfunctionFeb 4, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE RESPIRATORY THERAPIST WAS USING THE LIBERATOR MANIFOLD WITH THE LIBERATOR BRONCH ADAPTER AND NOTICED THE MANIFOLD HAD A LEAK AND IT SPRAYED WHEN IN-USE. THE RESPIRATORY THERAPIST AND THE ANESTHESIOLOGIST (WHO WAS IN THE PATIENT'S ROOM) BOTH HEARD THE LEAK AND WITNESSED THE SPRAY. IT APPEARED THE MANIFOLD WAS THE ISSUE, NOT THE BRONCH ADAPTER. THIS CONTINUED WHEN THE BRONCH ADAPTER WAS SWITCHED OUT FOR THE LIBERATOR CLOSED SUCTION CATHETER. THE PATIENT WAS ON A POSITIVE END-EXPIRATORY PRESSURE (PEEP) OF 15. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453246 ↗
• MalfunctionMar 31, 2021Fluid/Blood Leak; Fluid/Blood 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 3011270181-2021-00019 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE LIBERATOR CSC [CLOSED SUCTION CATHETER] SLEEVE FILLED WITH SECRETIONS AND SALINE WITHIN A FEW HOURS OF USE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599648 ↗
• MalfunctionMar 31, 2021Fluid/Blood Leak; Fluid/Blood 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 3011270181-2021-00018 FOR THE FIRST REPORT IT WAS REPORTED THAT THE LIBERATOR CSC [CLOSED SUCTION CATHETER] SLEEVE FILLED WITH SECRETIONS AND SALINE WITHIN A FEW HOURS OF USE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599612 ↗