Halyard 35113Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10680651351132), received between Mar 20, 2017 and May 3, 2023 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "AIR LEAKAGE OCCURRED DURING USE [OF THE ENDOTRACHEAL TUBE]. WHEN CHECKED ITS APPEARANCE, INFLATION VALVE AND PILOT BALLOON DETACHED." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860023 ↗
• MalfunctionFeb 19, 2020Leak/Splash; Leak/Splash

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 3011270181-2020-00025 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00026 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00028 FOR THE FOURTH REPORT. IT WAS REPORTED THAT THE CUSTOMER IS "FINDING THERE ARE BUBBLES/CONDENSATION/FLUID BUILD UP AROUND THE CUFF." NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9726525 ↗
• MalfunctionDec 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INFLATION LINE CAME OFF THE DEVICE. IT WAS FOUND 15 HOURS AFTER SURGERY. A BITE BLOCK WAS USED, AND THE NURSE ALSO NOTED THAT THE PATIENT'S HEAD DIRECTION HAD NOT CHANGED COMPARED TO PRIOR TO SURGERY. THEY DO NOT BELIEVE THE INFLATION LINE WAS DAMAGED BY THE PATIENT. THE MICROCUFF WAS REPLACED FOR A NEW ONE, AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9501587 ↗
• MalfunctionOct 21, 2019Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT AIR LEAKED FROM THE CUFF DURING USE. THE USER CHECKED THAT THE CUFF INFLATED PROPERLY BEFORE INTUBATING AND THERE WAS NO PROBLEM. THE INCIDENT WAS ALLEGED TO HAVE OCCURRED AFTER INTUBATING AND INFLATING THE CUFF. THE MICROCUFF WAS REPLACED FOR NEW ONE. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9214821 ↗
• MalfunctionApr 26, 2019Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT CUFF PRESSURE DECREASED EVEN RIGHT AFTER THE USER INFLATED THE CUFF. WHILE INTUBATING, THE USER INFLATED THE CUFF TO CHECK IT BUT THERE WAS NO PROBLEM. THE MICROCUFF WAS REPLACED FOR NEW ONE. NO PATIENT INJURY. IT WAS SUSPECTED THAT THE CUFF WAS TORN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8554802 ↗
• MalfunctionFeb 20, 2019Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THERE WAS A HOLE IN THE INFLATION LINE OF THE DEVICE AND AIR LEAKED DURING USE. THE CUFF WAS REPLACED FOR NEW DEVICE IMMEDIATELY. THE WAS NO REPORTED PATIENT INJURY. THE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Extubate

  MAUDE report 8354432 ↗
• MalfunctionFeb 15, 2019Disconnection; Disconnection

  IT WAS REPORTED THAT THE INFLATION LINE DISCONNECTED DURING USE. THE CUFF WAS IMMEDIATELY REPLACED FOR A NEW ONE WITH NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8345247 ↗
• MalfunctionSep 19, 2017Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TUBE WAS INSERTED, THE CUFF FAILED TO INFLATE. PER ADDITIONAL INFORMATION RECEIVED ON 13 SEP 2017, THE CUFF WAS NOT PRETESTED PRIOR TO INSERTION. THERE WAS NO INJURY TO THE PATIENT, NO BLEEDING, TISSUE DAMAGE, OR SKIN IRRITATION. ANOTHER TUBE WAS USED TO INTUBATE, WITH PRE-TEST OF THE CUFF PRIOR TO INSERTION. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6875398 ↗
• MalfunctionMar 20, 2017Partial Blockage; Partial Blockage

  PER ADDITIONAL INFORMATION RECEIVED 4 AUG 2017, THE PATIENT WAS UNDERGOING HEART SURGERY AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Respiratory Distress

  MAUDE report 6416706 ↗