Halyard 13222Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 10680651132229), received between Dec 12, 2016 and Feb 10, 2023 — classified as 2 deaths, 91 malfunctions.

The most frequently reported specific device problem is “Disconnection” (29 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 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2023Material Integrity Problem; Material Integrity Problem

  FDA MEDWATCH / FDA USER FACILITY REPORT # MW5113317 REPORTED, ¿A PATIENT WAS ABLE TO BITE THROUGH THE CUFF SUBGLOTTIC SUCTION ATTACHMENT TUBING TO THE ENDOTRACHEAL TUBE (ETT) DISCONNECTING THE SUCTION TUBING. THE ETT TUBE ITSELF WAS NOT COMPROMISED, NO INJURY TO THE PATIENT.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 16352975 ↗
• MalfunctionDec 22, 2022Material Integrity Problem; Material Integrity Problem

  FDA MEDWATCH / FDA USER FACILITY REPORT # MW5113317 REPORTED THAT ON (B)(6) 2022, ¿A PATIENT WAS ABLE TO BITE THROUGH THE CUFF SUBGLOTTIC SUCTION ATTACHMENT TUBING TO THE ENDOTRACHEAL TUBE (ETT) DISCONNECTING THE SUCTION TUBING. THE ETT TUBE ITSELF WAS NOT COMPROMISED, NO INJURY TO THE PATIENT.¿

  Patient problems: Foreign Body In Patient

  MAUDE report 16039828 ↗
• MalfunctionJul 14, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WITHOUT DIFFICULTY AND END-TIDAL CARBON DIOXIDE (ETCO2) MONITORING WAS CONFIRMED, THE TUBE WAS SECURED. SHORTLY AFTER A SLOW CUFF LEAK WAS NOTED. THE TUBE WAS CHANGED TO A NON-FAULTY CUFF TUBE; THE INTUBATION WAS UNEVENTFUL, THE PATIENT WAS STABLE, AND THERE WAS NO INJURY OR HARM REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15023160 ↗
• MalfunctionJul 13, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE ET (ENDO-TRACHEAL) TUBE THAT REQUIRED REINTUBATION WITH A NEW DEVICE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009307 ↗
• MalfunctionJun 9, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED 'DURING AN INTUBATION, CHECK THE TIGHTNESS OF THE BALLOON [CUFF] BEFORE PERFORMING THE PROCEDURE. ONCE THE PATIENT WAS INTUBATED, SIGNIFICANT LEAKS WERE OBSERVED. THE PATIENT WAS EXTUBATED AND THEN REINTUBATED.' THERE WAS NO REPORTED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651401 ↗
• MalfunctionMar 23, 2022Inflation Problem; Inflation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030647-2022-00099 FOR THE FIRST REPORT. THE FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5106967 REPORTED DURING INTUBATION OF A CRITICALLY ILL PATIENT THE AVANOS ENDOTRACHEAL TUBE CUFF (ETT) FAILED TO INFLATE. THE ETT WAS REPLACED AND THE PATIENT WAS INTUBATED AND PLACED ON THE VENTILATOR. THERE WAS NO REPORTED INJURY; NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT¿S CURRENT CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 13863325 ↗
• MalfunctionMar 23, 2022Inflation Problem; Inflation Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2022-00100 FOR THE SECOND REPORT. THE FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5106967 REPORTED DURING INTUBATION OF A CRITICALLY ILL PATIENT THE AVANOS ENDOTRACHEAL TUBE CUFF (ETT) FAILED TO INFLATE. THE ETT WAS REPLACED AND THE PATIENT WAS INTUBATED AND PLACED ON THE VENTILATOR. THERE WAS NO REPORTED INJURY; NO ADDITIONAL INFORMATION WAS PROVIDED CONCERNING THE PATIENT¿S CURRENT CONDITION.

  Patient problems: Insufficient Information

  MAUDE report 13863139 ↗
• MalfunctionDec 23, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AIR LEAKED FROM THE MICROCUFF AND WATER WAS NOTED INSIDE THE MICROCUFF. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2021 STATED THE DEVICE DID NOT HAVE AN AIR LEAK PROBLEM. THE USER FACILITY OBSERVED WATER INSIDE THE CUFF. THE DEVICE WAS EXCHANGED FOR A NEW DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 13077806 ↗
• MalfunctionJan 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE VENT CONNECTOR DETACHED DURING USE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 15-JAN-2021 INDICATED THE DETACHED CONNECTOR WAS NOTICED BY A WARNING ALARM. WHEN THE CONNECTOR WAS ATTEMPTED TO RE-INSERT TO THE TUBE, THE CONNECTION BETWEEN THEM WAS LOOSE AND COULD NOT BE USED ANY FURTHER. AN ALTERNATIVE CONNECTOR WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11236858 ↗
• MalfunctionApr 28, 2020Burst Container or Vessel; Pressure Problem; Burst Container or Vessel; Pressure Problem

  IT WAS REPORTED THAT WHILE THE PATIENT WAS BEING INTUBATED, THE CUFF BURST AND THE BALLOON WOULD NOT INFLATE. ANOTHER KIT WAS USED TO COMPLETE THE INTUBATION. PER ADDITIONAL INFORMATION RECEIVED 14 APR 2020, THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10005161 ↗
• MalfunctionJan 31, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 9611594-2020-00015 FOR THE FIRST EVENT. IT WAS INITIALLY REPORTED THE DEVICE "BROKE OR FAILED." ADDITIONAL INFORMATION RECEIVED 08-JAN-2020 STATED THE PATIENT WAS INTUBATED WITH A MICROCUFF DEVICE. AFTER FILLING THE CUFF WITH 20CC OF AIR THE CLINICIAN WAS UNABLE TO GET AN ADEQUATE SEAL. THE PATIENT WAS EXTUBATED AND ANOTHER MICROCUFF WAS UTILIZED, THE CLINICIAN WAS UNABLE TO GET AN ADEQUATE SEAL. ON THE THIRD ATTEMPT THE CLINICIAN USED A COOK INTUBATION DEVICE, THE PLACEMENT WAS SUCCESSFUL AND A ADEQUATE SEAL WAS ACHIEVED. THE CLINICIAN NOTED WHEN THEY USED THE COOK INTUBATION DEVICE THE PATIENT DEVELOPED A PNEUMOTHORAX. ON (B)(6) 2019 THE PATIENT EXPIRED FROM A PRE-EXISTING CONDITION. ADDITIONAL INFORMATION RECEIVED 23-JAN-2020 STATED THE PNEUMOTHORAX WAS IN THE RIGHT LUNG.

  Patient problems: Death

  MAUDE report 9653725 ↗
• MalfunctionJan 31, 2020Material Puncture/Hole; Material Puncture/Hole

  ADDITIONAL INFORMATION RECEIVED 07-JAN-2020 NOTED AN FDA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED AND STATED, "THE DOCTOR WAS INTUBATING THE PATIENT WITH AN 8.0 ENDO TRACHEAL TUBE (ETT) AND THE CUFF BLEW WHEN INFLATED WITH AIR."

  Patient problems: Extubate

  MAUDE report 9652618 ↗
• MalfunctionJan 31, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 9611594-2020-00016 FOR THE SECOND EVENT. IT WAS INITIALLY REPORTED THE DEVICE "BROKE OR FAILED." ADDITIONAL INFORMATION RECEIVED 08-JAN-2020 STATED THE PATIENT WAS INTUBATED WITH A MICROCUFF DEVICE. AFTER FILLING THE CUFF WITH 20CC OF AIR THE CLINICIAN WAS UNABLE TO GET AN ADEQUATE SEAL. THE PATIENT WAS EXTUBATED AND ANOTHER MICROCUFF WAS UTILIZED, THE CLINICIAN WAS UNABLE TO GET AN ADEQUATE SEAL. ON THE THIRD ATTEMPT THE CLINICIAN USED A COOK INTUBATION DEVICE, THE PLACEMENT WAS SUCCESSFUL AND A ADEQUATE SEAL WAS ACHIEVED. THE CLINICIAN NOTED WHEN THEY USED THE COOK INTUBATION DEVICE THE PATIENT DEVELOPED A PNEUMOTHORAX. ON (B)(6) 2019 THE PATIENT EXPIRED FROM A PRE-EXISTING CONDITION. ADDITIONAL INFORMATION RECEIVED 23-JAN-2020 STATED THE PNEUMOTHORAX WAS IN THE RIGHT LUNG.

  Patient problems: Death

  MAUDE report 9652613 ↗
• MalfunctionJan 21, 2020Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2020-00010 FOR THE FIRST EVENT. REFER TO 9611594-2020-00011 FOR THE SECOND EVENT. REFER TO 9611594-2020-00013 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE DURING USE THE ENDOTRACHEAL LOSS TIDAL VOLUME WHILE THE PATIENT WAS REQUIRING MECHANICAL VENTILATION. THE PATIENT HAD TO UNDERGO REINTUBATION. THE DEVISE WAS TESTED FOR INTEGRITY PRIOR TO PATIENT USE. ADDITIONAL INFORMATION RECEIVED 07-JAN-2020 NOTED AN FDA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED.

  Patient problems: Extubate

  MAUDE report 9613001 ↗
• MalfunctionJan 21, 2020Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2020-00010 FOR THE FIRST EVENT. REFER TO 9611594-2020-00011 FOR THE SECOND EVENT. REFER TO 9611594-2020-00012 FOR THE THIRD EVENT. IT WAS REPORTED THAT THE DURING USE THE ENDOTRACHEAL LOSS TIDAL VOLUME WHILE THE PATIENT WAS REQUIRING MECHANICAL VENTILATION. THE PATIENT HAD TO UNDERGO REINTUBATION. THE DEVISE WAS TESTED FOR INTEGRITY PRIOR TO PATIENT USE. ADDITIONAL INFORMATION RECEIVED 07-JAN-2020 NOTED AN FDA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED.

  Patient problems: Extubate

  MAUDE report 9612914 ↗
• MalfunctionJan 21, 2020Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2020-00010 FOR THE FIRST EVENT. REFER TO 9611594-2020-00012 FOR THE THIRD EVENT. REFER TO 9611594-2020-00013 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE DURING USE THE ENDOTRACHEAL LOSS TIDAL VOLUME WHILE THE PATIENT WAS REQUIRING MECHANICAL VENTILATION. THE PATIENT HAD TO UNDERGO REINTUBATION. THE DEVISE WAS TESTED FOR INTEGRITY PRIOR TO PATIENT USE. ADDITIONAL INFORMATION RECEIVED 07-JAN-2020 NOTED AN FDA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED.

  Patient problems: Extubate

  MAUDE report 9612828 ↗
• MalfunctionJan 21, 2020Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2020-00011 FOR THE SECOND EVENT. REFER TO 9611594-2020-00012 FOR THE THIRD EVENT. REFER TO 9611594-2020-00013 FOR THE FOURTH EVENT. IT WAS REPORTED THAT THE DURING USE THE ENDOTRACHEAL LOSS TIDAL VOLUME WHILE THE PATIENT WAS REQUIRING MECHANICAL VENTILATION. THE PATIENT HAD TO UNDERGO REINTUBATION. THE DEVISE WAS TESTED FOR INTEGRITY PRIOR TO PATIENT USE. ADDITIONAL INFORMATION RECEIVED 07-JAN-2020 NOTED AN FDA MEDWATCH/ FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED.

  Patient problems: Extubate

  MAUDE report 9612827 ↗
• MalfunctionNov 20, 2019Decrease in Pressure; Decrease in Pressure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2019-00237 FOR THE FIRST REPORT. REFER TO 9611594-2019-00238 FOR THE SECOND REPORT. IT WAS REPORTED THAT DURING THE EMERGENCY RESUSCITATION OF A PATIENT IN THE EMERGENCY ROOM, THE TUBE WAS FOUND TO HAVE A CUFF LEAK. THERE WAS NO HARM TO THE PATIENT, AS VENTILATION WAS SUCCESSFUL THROUGHOUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349291 ↗
• MalfunctionNov 20, 2019Decrease in Pressure; Decrease in Pressure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2019-00238 FOR THE SECOND REPORT. REFER TO 9611594-2019-00239 FOR THE THIRD REPORT. IT WAS REPORTED THAT DURING THE EMERGENCY RESUSCITATION OF A PATIENT IN THE EMERGENCY ROOM, THE TUBE WAS FOUND TO HAVE A CUFF LEAK. THERE WAS NO HARM TO THE PATIENT, AS VENTILATION WAS SUCCESSFUL THROUGHOUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349290 ↗
• MalfunctionNov 20, 2019Decrease in Pressure; Decrease in Pressure

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2019-00237 FOR THE FIRST REPORT. REFER TO 9611594-2019-00239 FOR THE THIRD REPORT . IT WAS REPORTED THAT DURING THE EMERGENCY RESUSCITATION OF A PATIENT IN THE EMERGENCY ROOM, THE TUBE WAS FOUND TO HAVE A CUFF LEAK. THERE WAS NO HARM TO THE PATIENT, AS VENTILATION WAS SUCCESSFUL THROUGHOUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9349289 ↗
• MalfunctionNov 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED 22-NOV-2019 STATED THE INCIDENT WAS NOTED WHEN THE RESPIRATORY THERAPIST (RT) WAS ATTEMPTING TO SUCTION THE PATIENT. THE RT NOTICED A PALPABLE KINK IN THE TUBE DURING AN ATTEMPTED SUCTIONING OF THE PATIENT. THE SUCTION CATHETER WOULD NOT EASILY INSERT INTO THE ENDOTRACHEAL TUBE (ETT). THE PHYSICIAN PERFORMED THE INITIAL INTUBATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314958 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW (B)(4) THE, "PATIENT WAS INTUBATED. SHORTLY AFTER INTUBATION, ETT TUBE HUB BROKE OFF AND REQUIRED REPLACEMENT WITH A NEW TUBE AND HUB." THE WAS NOT REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9314950 ↗
• MalfunctionOct 15, 2019Break

  PATIENT WAS INTUBATED. SHORTLY AFTER INTUBATION, ETT TUBE HUB BROKE OFF AND REQUIRED REPLACEMENT WITH A NEW TUBE AND HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9191402 ↗
• MalfunctionAug 13, 2019Disconnection; Disconnection

  PER ADDITIONAL INFORMATION RECEIVED 13 AUG 2019, THE STAFF BECAME AWARE OF THE ISSUE BY THE VENT ALARM SOUNDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8891225 ↗
• MalfunctionJul 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED ON 31-JUL-2019 INDICATED "IT WAS THE SUBGLOTTIC LINE THAT CAME DETACHED FROM THE ET [ENDOTRACHEAL] TUBE...THE TUBE REMAINED IN THE PATIENT UNTIL THEY WERE EXTUBATED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8837924 ↗