Halyard 35215Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10680651352153), received between Jul 7, 2017 and Jun 4, 2020 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2020Unintended Ejection

  ET TUBE EXCHANGE REQUIRED SECONDARY TO CUFF LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118354 ↗
• 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 SIXTH OF SIX REPORTS. REFER TO 3011270181-2020-00018 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00019 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00020 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00021 FOR THE FOURTH REPORT. REFER TO 3011270181-2020-00022 FOR THE FIFTH 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 9671265 ↗
• 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 FOURTH OF SIX REPORTS. REFER TO 3011270181-2020-00018 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00019 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00020 FOR THE THIRD 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 9670397 ↗
• 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 FIFTH OF SIX REPORTS. REFER TO 3011270181-2020-00018 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00019 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00020 FOR THE THIRD REPORT. REFER TO 3011270181-2020-00021 FOR THE FOURTH 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 9670396 ↗
• 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 3011270181-2019-00019 FOR THE FIRST REPORT. REFER TO 3011270181-2019-00020 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 8693908 ↗
• 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 3011270181-2019-00019 FOR THE FIRST REPORT, REFER TO 3011270181-2019-00021 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 8693903 ↗
• 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 3011270181-2019-00020 FOR THE SECOND REPORT. REFER TO 3011270181-2019-00021 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 8693902 ↗
• MalfunctionAug 9, 2018Inflation Problem; Inflation Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED AT LEAST THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3011270181-2018-00030 FOR THE FIRST REPORT; REFER TO 3011270181-2018-00031 FOR THE SECOND REPORT. IT WAS REPORTED THAT THERE WAS DEFLATION OF THE OUTER BALLOON, AND CONDENSATION APPEARED TO BE PRESENT IN THE BALLOON, BUT THERE WAS NO OBSERVED LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7766891 ↗
• MalfunctionAug 9, 2018Inflation Problem; Inflation Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED AT LEAST THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3011270181-2018-00030 FOR THE FIRST REPORT; REFER TO 3011270181-2018-00032 FOR THE THIRD REPORT. IT WAS REPORTED THAT THERE WAS DEFLATION OF THE OUTER BALLOON, AND CONDENSATION APPEARED TO BE PRESENT IN THE BALLOON, BUT THERE WAS NO OBSERVED LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7766888 ↗
• MalfunctionAug 9, 2018Inflation Problem; Inflation Problem

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED AT LEAST THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3011270181-2018-00031 FOR THE SECOND REPORT; REFER TO 3011270181-2018-00032 FOR THE THIRD REPORT. IT WAS REPORTED THAT THERE WAS DEFLATION OF THE OUTER BALLOON, AND CONDENSATION APPEARED TO BE PRESENT IN THE BALLOON, BUT THERE WAS NO OBSERVED LEAK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7766887 ↗
• MalfunctionJul 7, 2017Leak/Splash; Leak/Splash

  A MEDWATCH REPORT NUMBER (B)(4) WAS RECEIVED ON 19-JUN-2017. IT WAS REPORTED THAT, A FALL/TRAUMA PATIENT IN A C-COLLAR WAS INTUBATED WITH A GLIDESCOPE WITH SLIGHT DIFFICULTY. THE BALLOON WAS PRE-TESTED THE ENDOTRACHEAL TUBE PASSED WITHOUT COMPLICATION, AND THE PATIENT WAS INTUBATED. INITIALLY WITH THE APPROPRIATE PILOT BALLOON INFLATION WITH APPROXIMATELY 15CC OF AIR. THE RESPIRATORY THERAPIST NOTED THE PATIENT POSSIBLY HAD AIR LEAK (TIDAL VOLUME DOWN FROM 600S TO 400S; AUDIBLE). THE PILOT BALLOON WAS CHECKED AND WAS UNABLE TO MAINTAIN PRESSURE DESPITE REPEATED INFLATIONS WITH A SYRINGE. THE RESPIRATORY THERAPIST ATTACHED A 3-WAY STOPCOCK INSUFFLATION PORT AS A CAP AND THE PILOT BALLOON NOW INFLATED, IMPROVING VENTILATOR VOLUMES (500S). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6692929 ↗