Halyard 35112Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10680651351125), received between Jan 11, 2017 and Jul 14, 2023 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT, ON (B)(6) 2023, THE CUFF BROKE AFTER INTUBATION; THERE WAS NO REPORTED PATIENT INJURY OR MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 17325143 ↗
• MalfunctionDec 28, 2021Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THE "CUFF PRESSURE DECREASED RIGHT AFTER INFLATING THE CUFF." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION STATED (B)(6) 2021 STATED THE DEVICE WAS REMOVED FROM THE PATIENT BECAUSE DECREASED CARBON DIOXIDE (CO2) MONITOR MEASUREMENT WAS OBSERVED AFTER 16 MINUTES OF USE. "THERE WAS NO OBVIOUS LEAK ON THE CUFF BUT THE DOCTOR DECIDED TO EXCHANGE A DEVICE FOR A NEW ONE TO SECURE THE CUFF FUNCTION."

  Patient problems: Abnormal Blood Gases

  MAUDE report 13101552 ↗
• MalfunctionJun 24, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MICROCUFF'S CONNECTOR WAS REMOVED AND Y-ADAPTERS FROM ANOTHER DEVICE WERE ATTACHED INSTEAD; HOWEVER, THEY DETACHED. THEY WERE TEMPORARILY TIED WITH CABLE TIE. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 09-JUN-2021 CONFIRMED THE MICROCUFF'S CONNECTOR WAS NOT USED. ADDITIONAL INFORMATION RECEIVED 11-JUN-2021 INDICATED THE PRODUCT WAS IN PLACE FOR APPROXIMATELY 2 WEEKS BEFORE THE REPORTED EVENT OCCURRED. THE EVENT WAS NOTICED BECAUSE OF AN ALARM. FURTHER ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12061919 ↗
• 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 SECOND OF FOUR REPORTS. REFER TO 3011270181-2020-00025 FOR THE FIRST REPORT. REFER TO 3011270181-2020-00027 FOR THE THIRD 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 9726517 ↗
• MalfunctionJan 30, 2020Inflation Problem; Inflation Problem

  ADDITIONAL INFORMATION RECEIVED 13-FEB-2020 INDICATED THE PRODUCT WAS NOT ALTERED IN ANY WAY PRIOR TO USE. THE INCIDENT DID NOT OCCUR DURING TRANSPORT AND THE PATIENT WAS NOT HAND BAGGED. "THE TUBE WAS COMING OUT." THE EVENT OCCURRED "WITHIN 2 WEEKS" OF USE. IT IS UNKNOWN HOW MUCH PRESSURE WAS USED TO INFLATE THE BALLOON AND THERE WAS NOT ANYTHING UNIQUE ABOUT THE PATIENT OR PROTOCOL USED. THE AMOUNT OF FORCE APPLIED TO THE TUBE IS UNKNOWN AND THE EVENT WAS NOT DUE TO A KINK IN THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9646524 ↗
• MalfunctionJun 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE "CAREGIVER NOTICED THE [ENDOTRACHEAL] TUBE PILOT BALLOON BROKE OFF FROM THE PILOT LINE. THEY THINK IT COULD BE DUE TO PILOT LINE BEING CONSTANTLY BENT AND/OR CONSTANTLY WARM. CAREGIVER MENTIONED THAT IT DOES NOT APPEAR TO HAVE BEEN CUT AS THEY WOULD HAVE EXPECTED THE POINT OF "DETATCHMENT" TO BE FARTHER ABOVE THE BALLOON. THEY ALSO WONDER IF THE LINE WAS CONSTANTLY BEING BENT AND WARM DUE TO HAVING THE PATIENT SWADDLED AND IN A RADIANT WARMER, IF IT WOULD MAKE THE LINE MORE SUSCEPTIBLE TO BREAKAGE. CURRENTLY, THE PATIENT IS STILL INTUBATED WITH THE ETT [ENDOTRACHEAL TUBE]. PATIENT DID NOT SUFFER ANY ADVERSE REACTION TO THE DETACHMENT OF THE PILOT BALLOON...THIS PATIENT HAS BEEN INTUBATED WITH THE SAME TUBE SINCE 5/6 [(B)(6) 2019]¿CURRENTLY, THE MEDICAL TEAM DOES NOT HAVE ANY IMMEDIATE PLANS OF EXTUBATING THIS PATIENT, AS THEY ARE WANTING THEM TO REST AND GROW."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8730336 ↗
• MalfunctionApr 29, 2019Break; Break

  IT WAS REPORTED "ET TUBE GREEN CONNECTOR SNAPPED OFF THE STEM. ANOTHER CONNECTOR FROM A DIFFERENT TUBE HAD TO BE USED. NO PATIENT INJURY WAS REPORTED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8563260 ↗
• MalfunctionMar 16, 2019Decrease in Pressure; Decrease in Pressure

  PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2019 THE REPORTED INCIDENT WAS FOUND RIGHT AFTER PLACING THE MICROCUFF IN THE PATIENT. THE PHYSICIAN THOUGHT THIS MIGHT HAVE HAPPENED BECAUSE OF HIS/HER PROCEDURE. NO INFORMATION ON THEIR PROCEDURE WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8426985 ↗
• MalfunctionFeb 13, 2019Break; Break

  IT WAS REPORTED THAT AFTER INTUBATION AND CONNECTION TO THE VENTILATION SYSTEM, THE STANDARD CONNECTOR TO THE MICROCUFF TUBE BROKE OFF. THERE WAS NO FORCE USED, ONLY SOME PRESSURE. THE TUBE WAS THEN SHORTENED AND CONNECTED WITH A NEW DEAD SPACE REDUCER WITH FILTER. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED 28-JAN-2019 STATED THE USER REPORTED NO INJURY TO THE PATIENT AND THAT THE CONNECTOR WAS REPLACED FOR A NEW ONE CONNECTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8337921 ↗
• MalfunctionJun 18, 2018Air Leak; Air Leak

  IT WAS REPORTED THAT THE CUFF PRESSURE DROPPED OVER TIME. THE CUFF REQUIRED RE-INFLATION SEVERAL TIMES EACH SHIFT. THE HOSPITAL IS USING NEW VENTILATOR MACHINES THAT ALARM WHEN AN AIR LEAK IS DETECTED. PER ADDITIONAL INFORMATION RECEIVED 8 JUN 2018, THE NURSE REPORTS THE RISK OF INJURY TO THE PATIENT IS LOW, AS THE VENTILATOR ALARM ENSURES THAT THE NURSES KNOW WHEN TO RE-INFLATE THE CUFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7609309 ↗
• MalfunctionJun 13, 2018Break; Break

  IT WAS REPORTED THE GREEN ADAPTOR ON THE ENDOTRACHEAL (ET) TUBE SNAPPED DURING USE. WHEN THE NURSE REMOVED THE CONNECTOR FROM THE END OF THE TUBE IN ORDER TO INSERT THE IN-LINE SUCTION, THE CONNECTOR SNAPPED IN HALF LEAVING HALF OF THE DEVICE STUCK INSIDE THE ET TUBE. THE PATIENT DESATURATED DURING THE TIME IT TOOK TO FIX THE BROKEN END. THE PATIENT ALSO BECAME BRADYCARDIC AND DID REQUIRE SOME TIME TO RESATURATE, BUT EVENTUALLY THE PATIENT BECAME STABLE AGAIN. THE DEVICE WAS IN USE FOR ONE HOUR PRIOR TO THE EVENT. A PROCEDURE WAS UNDERTAKEN TO REPLACE THE PRODUCT. THE FAULTY GREEN ADAPTOR WAS CUT OFF AND REPLACED WITH A NEW ET TUBE END. LATER THAT DAY THE PATIENT WAS TO ANOTHER FACILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bradycardia

  MAUDE report 7598230 ↗
• MalfunctionDec 6, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE PILOT BALLOON CAME AWAY FROM THE INFLATION LINE DURING USE. THE ENDOTRACHEAL TUBE WAS BEING USED WITHOUT INFLATION OF THE CUFF, SO THERE WAS NO ISSUE WITH DEFLATION. THE TUBE IS STILL IN USE ON THE PATIENT WITH THE INFLATION LINE CLOSED OFF WITH A PIECE OF TAPE. THIS INCIDENT OCCURRED IN THE NEONATAL INTENSIVE CARE UNIT. THERE WAS NO IMPACT ON THE PATIENT'S HEALTH. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088834 ↗
• MalfunctionDec 1, 2017Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT IMMEDIATELY AFTER THE MICROCUFF WAS PLACED, THE PATIENT COULD NOT BE VENTILATED. THE USER ATTEMPTED TO SUCTION OUT THE TUBE, BUT IT WAS UNSUCCESSFUL, SO A REPLACEMENT DEVICE WAS REQUIRED. IT WAS NOTED THAT IN THE REMOVED TUBE, THERE WAS A HARD PLUG. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2017, THE MICROCUFF WAS PLACED NASALLY, WITHOUT PERFORMING SUCTION FIRST. NORMALLY, THE PATIENT'S NOSE IS SUCTIONED PRIOR TO PLACING THE MICROCUFF. THE TUBE WAS PLACED WITHOUT A GUIDING DEVICE. THE CUFF PRESSURE WAS SET AT 5CM WATER. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7076814 ↗
• MalfunctionNov 17, 2017Break; Break

  IT WAS REPORTED THAT THE INFLATION LINE BROKE OFF INTO THE PATIENT'S MOUTH A DAY AFTER THE PATIENT WAS INTUBATED. THE PIECE WAS RETRIEVED BY THE NURSE, HOWEVER, THE PATIENT WAS EXTUBATED AND RE-INTUBATED. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7042656 ↗
• MalfunctionSep 22, 2017Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE BECAME OCCLUDED WITH TRACHEAL SECRETIONS. TWELVE HOURS AFTER SURGERY, AN INTENSIVE CARE UNIT NURSE FELT THAT THERE WAS SOMETHING WRONG WITH THE GAS EXCHANGE IN THE PATIENT. THE NURSE AND A DOCTOR INVESTIGATED THE NURSE AND FOUND THE OCCLUSION. PER ADDITIONAL INFORMATION RECEIVED 4 SEP 2017, THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION, OTHER THAN EXTUBATION AND RE-INTUBATION. THE PATIENT HAD BEEN IN THE INTENSIVE CARE UNIT FOR A WHILE BEFORE THE SURGERY. THE APPROPRIATE ENDOTRACHEAL TUBE SIZE FOR THE PATIENT WAS 3.0 MM, HOWEVER THE DOCTOR USED A 3.5 MM TUBE BECAUSE OF THE PATIENT'S SECRETIONS. THERE WERE NO ISSUES DURING THE SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6887640 ↗
• MalfunctionFeb 20, 2017Air Leak; Air Leak

  IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO INFLATE THE MICROCUFF BALLOON DUE TO LEAKS DURING THE MECHANICAL VENTILATION. THIS RESULTED IN NON OPTIMAL VENTILATION OF THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Hypoventilation

  MAUDE report 6342819 ↗
• MalfunctionJan 11, 2017Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THERE WAS ENDOTRACHEAL TUBE OBSTRUCTION BY VISCOUS BLOOD OR SPUTUM. THE HOSPITAL COULD NOT PROVIDE INFORMATION ON WHETHER OR NOT THE PATIENT REQUIRED RE-INTUBATION. THERE WAS NO REPORTED INJURY TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6243427 ↗