Halyard 35216Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10680651352160), received between Apr 27, 2017 and Aug 3, 2020 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2020Gas/Air Leak

  AT THE BEGINNING OF SHIFT, NOTED AN AUDIBLE CUFF LEAK ON PTS ETT. VOLUMES MISMATCHED ON VENT (I.E. IN = 500, OUT = 300). NOT DESATURATING. CALLED RT TO BEDSIDE. AIR ADDED TO ETT CUFF AND STOPCOCK ADDED TO PILOT BALLOON - HAS BEEN WORKING IN CASES W/ SLOW CUFF LEAKS. RTS ADDED ABOUT 20CCS TO CUFF W/ STOPCOCK, STILL NOTABLE CUFF LEAK. MICU TEAM AND FELLOW UPDATED. MICU FELLOW CAME IN AND EXCHANGED ETT OVER A BOUGIE. CHARGE RN AWARE. ETT INFO: #7.5 MICROCUFF ORONASAL TUBE. NO LOT OR ID # ON TUBE. ONCE THE TUBE WAS OUT, RE-TESTED CUFF W/ AIR AND IT APPEARED INTACT. AFTER ETT EXCHANGE (MEDS INCLUDED ROC, ETOMIDATE, PROPOFOL), PATIENT DID REQUIRE AN INCREASE IN LEVO AFTER DROPPING HIS BLOOD PRESSURE. WAS TEMPORARY AND WE WERE ABLE TO DOWN-TITRATE LEVO AFTERWARDS.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 10355409 ↗
• MalfunctionJun 4, 2020Gas/Air Leak

  RN INFORMED RESPIRATORY TECH THAT PT HAD AN AUDIBLE CUFF LEAK ON PT ET TUBE. RESPIRATORY TECH INSPECTED PT ET TUBE AND CONFIRMED THAT A CUFF LEAK WAS PRESENT. RESPIRATORY TECH FIXED PT CUFF LEAK. RESPIRATORY TECH LEFT ROOM. RN RETURNED TO RESPIRATORY TECH WITHIN 5-10 MINS STATING THAT THE CUFF WAS LEAKING AGAIN. RESPIRATORY TECH USED MANOMETER TO MEASURE CUFF PRESSURE AND THE MANOMETER READ BELOW THE GREEN ZONE. RESPIRATORY TECH THEN RE-INFLATED CUFF WITH MANOMETER AND DISCONNECTED THE MANOMETER. RESPIRATORY TECH THEN RETESTED CUFF PRESSURE WITH MANOMETER AND THE ET TUBE CUFF PRESSURE HAD FALLEN SIGNIFICANTLY AND WAS NO LONGER HOLDING A PROPER CUFF PRESSURE. RESPIRATORY TECH INFORMED MEDICAL DOCTOR WHO CALLED ANESTHESIA AND ASSISTED IN ET TUBE EXCHANGE ON THE PT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118391 ↗
• MalfunctionJun 4, 2020Adverse Event Without Identified Device or Use Problem

  PATIENT WAS NOTED TO HAVE ACUTE DESATURATION. ET TUBE NOTED TO BE AT 20 CM.

  Patient problems: Low Oxygen Saturation

  MAUDE report 10118332 ↗
• MalfunctionJun 4, 2020Leak/Splash

  LEAKING ETT, REQUIRING EXCHANGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118242 ↗
• MalfunctionJun 4, 2020Leak/Splash

  PT ON VENT, VENT ALARM SOUNDED, PT NOTED TO HAVE 0 TV AND 0 MV. PT THEN BECAME BRADYCARDIC FOLLOWED BY ASYSTOLE. HR RETURNED AFTER ATROPINE. ETT CUFF THEN NOTED TO HAVE A LARGE CUFF LEAK, AIR ADDED TO BALLOON AND ANESTHESIA PAGED TO CHANGE ETT. ONCE TUBE REMOVED BALLOON NOTED TO HAVE WATER IN IT.

  Patient problems: Bradycardia; No Code Available

  MAUDE report 10118240 ↗
• MalfunctionFeb 5, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF SIX REPORTS. REFER TO 3011270181-2020-00018 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00019 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00021 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00022 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00023 FOR THE SIXTH REPORT. IT WAS REPORTED THAT OVER THE PAST 21-30 DAYS THE USER FACILITY EXPERIENCED MULTIPLE INCIDENTS OF THE ETT [ENDOTRACHEAL TUBE] DEVELOPING TEARS IN THE CUFF. THE TEARS OCCURRED DURING USE WITH MULTIPLE DOCTORS WHO WERE ALL VERY FAMILIAR WITH USING THE PRODUCT. NO PATIENT INJURIES; HOWEVER, ALL INCIDENTS REQUIRED PATIENT TO BE REINTUBATED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 28-JAN-2020 INDICATED "WE HAD A TOTAL OF 6 ETT CHANGES DUE TO CUFF FAILURE...IT WAS NOT THE SAME PATIENT EACH TIME. THE TEARS WERE NOTED IN THE CUFF ITSELF UPON REMOVAL OF THE ETT, BUT WAS NOT NOTED PRIOR TO INSPECTION."

  Patient problems: Extubate

  MAUDE report 9670399 ↗
• MalfunctionFeb 4, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF SIX REPORTS. REFER TO 3011270181-2020-00019 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00020 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00021 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00022 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00023 FOR THE SIXTH REPORT. IT WAS REPORTED THAT OVER THE PAST 21-30 DAYS THE USER FACILITY EXPERIENCED MULTIPLE INCIDENTS OF THE ETT [ENDOTRACHEAL TUBE] DEVELOPING TEARS IN THE CUFF. THE TEARS OCCURRED DURING USE WITH MULTIPLE DOCTORS WHO WERE ALL VERY FAMILIAR WITH USING THE PRODUCT. NO PATIENT INJURIES; HOWEVER, ALL INCIDENTS REQUIRED PATIENT TO BE REINTUBATED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 28-JAN-2020 INDICATED "WE HAD A TOTAL OF 6 ETT CHANGES DUE TO CUFF FAILURE...IT WAS NOT THE SAME PATIENT EACH TIME. THE TEARS WERE NOTED IN THE CUFF ITSELF UPON REMOVAL OF THE ETT, BUT WAS NOT NOTED PRIOR TO INSPECTION."

  Patient problems: Extubate

  MAUDE report 9663252 ↗
• MalfunctionFeb 4, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF SIX REPORTS. REFER TO 3011270181-2020-00018 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00020 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00021 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00022 FOR THE FIFTH REPORT. REFER TO 3011270181-2020-00023 FOR THE SIXTH REPORT. IT WAS REPORTED THAT OVER THE PAST 21-30 DAYS THE USER FACILITY EXPERIENCED MULTIPLE INCIDENTS OF THE ETT [ENDOTRACHEAL TUBE] DEVELOPING TEARS IN THE CUFF. THE TEARS OCCURRED DURING USE WITH MULTIPLE DOCTORS WHO WERE ALL VERY FAMILIAR WITH USING THE PRODUCT. NO PATIENT INJURIES; HOWEVER, ALL INCIDENTS REQUIRED PATIENT TO BE REINTUBATED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 28-JAN-2020 INDICATED "WE HAD A TOTAL OF 6 ETT CHANGES DUE TO CUFF FAILURE...IT WAS NOT THE SAME PATIENT EACH TIME. THE TEARS WERE NOTED IN THE CUFF ITSELF UPON REMOVAL OF THE ETT, BUT WAS NOT NOTED PRIOR TO INSPECTION."

  Patient problems: Extubate

  MAUDE report 9663246 ↗
• MalfunctionFeb 1, 2020Partial Blockage; Inflation Problem; Partial Blockage; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT "STARTED TO EXPERIENCE VOLUME LOSS ON THE VENT. THE RT [RESPIRATORY TECHNICIAN] ADDED MORE AIR INTO THE PILOT BALLOON HOPING THIS WOULD RESOLVE THE ISSUE BUT THE PATIENT STILL EXPERIENCED SUBSTANTIAL VOLUME LOSS. THEY DECIDED TO INTUBATE THE PATIENT WITH A SHILEY (COVIDIEN) NON-EVAC TUBE AND HIS VOLUMES RETURNED TO NORMAL. THEY SEEM TO THINK THAT THE ISSUE IS WITH A CLOG OR BLOCKAGE IN THE PILOT BALLOON. THE RT ADDED 10CC OF AIR INTO THE PILOT BALLOON AND THE CUFF INFLATED BUT THE PILOT BALLOON REMAINED TOTALLY DEFLATED. THEY ALSO STATED THAT THE CUFF DOES NOT SEEM TO BE AS STRONG AS IT ONCE WAS." ADDITIONAL INFORMATION RECEIVED 24-JAN-2020 INDICATED THAT THE SCENARIO WAS NOTICED AFTER THE PRODUCT WAS IN USE ON A PATIENT. THE ETT [ENDOTRACHEAL TUBE] WAS TESTED FOR INTEGRITY PRIOR TO PATIENT USE. THE PATIENT WAS REQUIRED TO UNDERGO REINTUBATION. LOSS OF TIDAL VOLUME WAS NOTED WHILE THE PATIENT WAS REQUIRING MECHANICAL VENTILATION.

  Patient problems: Respiratory Distress

  MAUDE report 9656807 ↗
• MalfunctionJun 12, 2019Pressure Problem; Pressure Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2019-00022 FOR THE FIRST REPORT. REFER TO 3011270181-2019-00023 FOR THE SECOND REPORT. IT WAS REPORTED THAT "WE WERE INFORMED OF A HALYARD MICROCUFF ENDOTRACHEAL TUBE'S CUFF THAT WOULDN'T HOLD AIR BECAUSE A LEAK WAS PRESENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8693915 ↗
• MalfunctionJun 12, 2019Pressure Problem; Pressure Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2019-00022 FOR THE FIRST REPORT. REFER TO 3011270181-2019-00024 FOR THE THIRD REPORT. IT WAS REPORTED THAT "WE WERE INFORMED OF A HALYARD MICROCUFF ENDOTRACHEAL TUBE'S CUFF THAT WOULDN'T HOLD AIR BECAUSE A LEAK WAS PRESENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8693909 ↗
• MalfunctionJun 12, 2019Pressure Problem; Pressure Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2019-00023 FOR THE SECOND REPORT. REFER TO 3011270181-2019-00024 FOR THE THIRD REPORT. IT WAS REPORTED THAT "WE WERE INFORMED OF A HALYARD MICROCUFF ENDOTRACHEAL TUBE'S CUFF THAT WOULDN'T HOLD AIR BECAUSE A LEAK WAS PRESENT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8693906 ↗
• MalfunctionJan 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED 14-JAN-2019 STATING, THE PATIENT WAS INTUBATED (B)(6) 2018 AT 4PM AND THE DEVICE WAS IN PLACE UNTIL THE INCIDENT ON (B)(6) 2018 AT 11 AM. THE PROCEDURE WAS UNEVENTFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8233324 ↗
• MalfunctionJun 16, 2017Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED ON 11-JUL-2017 FOR USER FACILITY REPORT ¿ (B)(4). THE USER FACILITY REPORT STATES THAT THE EVENT DATE WAS (B)(6) 2017. CORRECTION: THE ISSUE WAS IDENTIFIED WITHIN MINUTES AND THE TUBE WAS CHANGED OVER A BOUGIE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6648243 ↗
• MalfunctionApr 27, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER BEING INTUBATED WITH AN 8.0 MICROCUFF ENDOTRACHEAL TUBE (ETT) ON (B)(6) 2017, THE PATIENT HAD TO BE EXTUBATED AND REINTUBATED WITH AN ETT TUBE WITH A POLYVINYL CHLORIDE CUFF FROM A DIFFERENT MANUFACTURER (SHERIDAN). THE REMOVED 8.0 MICROCUFF APPEARED TO HAVE BEEN DAMAGED OR TORN AWAY FROM THE TUBE ITSELF. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS DIFFICULTY WITH THE INTUBATION, AND THE CLINICIAN THEN USED THE STYLET WITH A GLIDESCOPE. WITH THE CUFF PRESSURE WAS INITIALLY CHECKED IT READ 50 CMH2O, THEN WAS REDUCED TO 30 CMH2O. NO BITE BLOCK OR ORAL AIRWAY WAS USED. THE PATIENT VOMITED DURING POST INTUBATION ATTEMPTS. NO FURTHER INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6526123 ↗