Halyard 35214Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10680651352146), received between Apr 6, 2017 and Jun 4, 2020 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2020Leak/Splash

  ETT LEAK, REQUIRING EXCHANGE OF TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118251 ↗
• MalfunctionJun 4, 2020Leak/Splash; Therapeutic or Diagnostic Output Failure

  FAILED ETT CUFF. PATIENT INTUBATED FOR ANGIOEDEMA. SINGLE ATTEMPT PASSED GENTLY USING GLIDESCOPE HYPERANGULATED BLADE. NOTHING UNUSUAL ABOUT THE INTUBATION. TUBE PASSED EASILY. CUFF HAD IMMEDIATE LEAK. REPLACED OVER BOUGIE EASILY. THIS WAS A 7.5 MICROCUFF ETT KEPT BY THE RESPIRATORY THERAPIST. THE TUBE WAS PLACED UNDER WATER AND INFLATED. LEAK APPEARS TO BE IN THE DISTAL CUFF. PILOT BALLOON AND LINE APPEARED UNDAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10118224 ↗
• MalfunctionAug 8, 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 3011270181-2018-00027 FOR THE FIRST REPORT; REFER TO 3011270181-2018-00028 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 7764544 ↗
• MalfunctionAug 8, 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 3011270181-2018-00028 FOR THE SECOND REPORT; REFER TO 3011270181-2018-00029 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 7764534 ↗
• MalfunctionAug 8, 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 3011270181-2018-00027 FOR THE FIRST REPORT; REFER TO 3011270181-2018-00029 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 7764532 ↗
• MalfunctionApr 6, 2017Bent; Kinked; Bent; Kinked

  IT WAS REPORTED ON 15-MAR-2017 BY FDA USER FACILITY REPORT: (B)(4) THAT A PATIENT WAS INTUBATED WITH AN ENDOTRACHEAL TUBE (ETT) FOR SEVERAL DAYS. THE VENTILATOR IS ON A HEATED CIRCUIT. THE HEATED CIRCUIT HEATS UP THE ENDOTRACHEAL TUBE CAUSING IT TO BECOME PLIABLE. THE TUBE IS NOTED TO BEND EASILY CAUSING KINKING. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO THE PATIENT OR REQUIRED MEDICAL INTERVENTION. ADDITIONAL INFORMATION WAS RECEIVED ON 20-MAR-2017 FROM THE INITIAL REPORTER THAT STATES, THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME TO REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462839 ↗