Halyard 35114Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10680651351149), received between Nov 27, 2019 and Feb 4, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2022Break; Break

  IT WAS REPORTED THAT 24-HOURS AFTER PLACING THE TUBE, THE INFLATION TUBE DETACHED AND THERE WAS A BITE MARK ON THE TUBE ITSELF. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13460515 ↗
• MalfunctionSep 29, 2020Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN AIR WAS INJECTED FROM INFLATION VALVE, THE PILOT BALLOON INFLATED BUT CUFF DID NOT INFLATE. IT WAS FOUND DURING USE. THE PRODUCT WAS REPLACED FOR NEW ONE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10603044 ↗
• 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 FOURTH OF FOUR REPORTS. REFER TO 3011270181-2020-00025 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00026 FOR THE SECOND REPORT. REFER TO 3011270181-2020-00027 FOR THE THIRD 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 9726528 ↗
• MalfunctionNov 27, 2019Decrease in Pressure; Decrease in Pressure

  IT WAS ORIGINALLY REPORTED THAT THE CUFF WOULD NOT HOLD PRESSURE. IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. PER ADDITIONAL INFORMATION RECEIVED 15 NOV 2019, THE PROBLEM OCCURRED DURING USE ON PATIENT. THE MICROCUFF WAS REPLACED WITH A NEW ONE. THEE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9383109 ↗