Halyard 35111Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10680651351118), received between Jan 16, 2017 and Apr 5, 2023 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Partial Blockage” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Detachment of Device or Device Component

  PATIENT WAS INTUBATED WITH 3.0 ETT. WHILE AT MRI, BLUE CAP FROM END OF ETT SEPARATED FROM TUBE THREE TIMES. PATIENT HAD DESATURATIONS ASSOCIATED WITH EACH EVENT AND REQUIRED MANUAL BAGGING AFTER BLUE CAP WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16681547 ↗
• MalfunctionJan 27, 2022Crack; Crack

  IT WAS REPORTED THAT THE SMART CUFF FIT INTO THE MICRO-CUFF INFLATION VALVE BUT THE CONNECTION WAS TOO TIGHT AND THE ASSEMBLY CAME OFF. ADDITIONAL INFORMATION RECEIVED 11JAN2022 STATED THE PATIENT¿S ENDOTRACHEAL TUBE (ET) TUBE WAS EXCHANGED. THERE WAS NO INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED 12JAN2022 STATED THE SMART-CUFF TUBE HAD A SMALL CRACK. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13373655 ↗
• MalfunctionDec 22, 2020Partial Blockage; Partial Blockage

  ADDITIONAL INFORMATION RECEIVED 25-DEC-2020 INDICATED THE DEVICE WAS USED BY ORAL INTUBATION. THE TUBE WAS CLOGGED AND THE PATIENT HAD TO BE EXTUBATED AND RE-INTUBATED BY USING A NEW DEVICE OF THE SAME MODEL.

  Patient problems: No Code Available

  MAUDE report 11056695 ↗
• MalfunctionMar 3, 2020Gas/Air Leak; Pressure Problem; Gas/Air Leak; Pressure Problem

  IT WAS REPORTED THAT "AIR LEAKED FROM THE TUBE DURING USE. A DOCTOR NOTICED AN UNNATURAL FEELING OF THE TUBE ON THE DAY THAT THE TUBE WAS PLACED IN THE PATIENT, BUT IT WAS USED FOR A COUPLE OF DAYS WATCHING ITS STATES OR CHANGES. VENTILATOR¿S ALARM DID NOT RING. THE TUBE WAS REPLACED FOR NEW ONE 3 DAYS LATER. WHEN THE DOCTOR CHECKED THE TUBE, THERE WAS AN AIR LEAK AROUND FROM THE ROOT OF THE INFLATING TUBE. THE PATIENT¿S HOSPITALIZATION IN ICU WAS EXTENDED, BUT THE PATIENT¿S CONDITION DID NOT BECOME SEVERE." PATIENT WAS MOVED TO A WARD FACILITY. ADDITIONAL INFORMATION RECEIVED 19-FEB-2020 INDICATED THAT "BECAUSE OF BRONCHITIS, THE PATIENT STARTED TO UNDERGO ARTIFICIAL RESPIRATION SINCE 24-JAN-2020. AN ENDOTRACHEAL TUBE WAS EXTUBATED AND THE NEW ONE WAS INTUBATED ON 30-JAN-2020. THOUGH THE SAME SIZE TUBE WAS PLACED IN THE PATIENT, THERE WAS AN OBVIOUS LEAK RIGHT AFTER INTUBATING. FIRSTLY, LEAKAGE FROM THE CUFF WAS SUSPECTED, SO THE CUFF PRESSURE WAS ADJUSTED. BUT THE PRESSURE DID NOT DECREASE. IT SEEMED THERE WAS NO LEAK FROM THE CUFF. SECONDLY, THE ARTIFICIAL VENTILATOR WAS SUSPECTED FOR THE LEAKAGE, BUT THE LEAKAGE CONTRIBUTED EVEN AFTER CHANGING THE VENTILATOR. ON 06-FEB-2020, TH

  Patient problems: Extubate

  MAUDE report 9782428 ↗
• 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 FIRST OF FOUR REPORTS. REFER TO 3011270181-2020-00026 FOR THE SECOND 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 9726527 ↗
• MalfunctionDec 16, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THE ENDOTRACHEAL TUBE (ETT) HAD A "POSSIBLE HOLE OR CRACK THAT WAS NOT NOTICED UPON INSERTION." THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 26-NOV-2019 STATED THE PATIENT WAS INTUBATED DUE TO WORK OF BREATHING (WOB) AND SUSTAINED DESATURATIONS. ABOUT 2-HOURS AFTER THE PATIENT WAS INTUBATED THE RESPIRATORY THERAPIST (RT) WAS BAG/SALINE SUCTIONING THE PATIENT AND NOTICED BUBBLES COMING FROM UNDERNEATH THE TAPE AROUND THE ETT. SALINE WAS COMING OUT OF THE PORT AND BUBBLES WERE COMING UP THROUGH THE CLOTH TAPE. THE PATIENT EXPERIENCED LOSS OF VOLUMES ON THE VENTILATOR AND THE PATIENT'S SATURATIONS WERE NOT WITHIN THE DESIRED RANGE. THE PATIENT REQUIRED REINTUBATION WITH ANOTHER ETT.

  Patient problems: Extubate; Low Oxygen Saturation

  MAUDE report 9474840 ↗
• MalfunctionOct 17, 2019Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUFF BROKE. PER ADDITIONAL INFORMATION RECEIVED 01 OCT 2019, THERE WAS NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED 08 OCT 2019, THE INCIDENT OCCURRED ON THE THIRD DAY AFTER INTUBATION. THE PATIENT WAS TO BE EXTUBATE AT THAT TIME, SO THE MICROCUFF AND TESTED FOR LEAKS. A PINHOLE LEAK WAS DISCOVERED IN THE MIDDLE OF THE CUFF. THE CUFF PRESSURE WAS 20CM H2O.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204347 ↗
• MalfunctionAug 9, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP ON 19 AUG 2019, THE CUSTOMER PUTS TAPE IN THE MIDDLE OR HALFWAY DOWN THE INFLATION LINE SO THAT THE PILOT BALLOON CONNECTION WAS NOT BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8878735 ↗
• MalfunctionMar 16, 2019Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE CUFF WAS DAMAGED DURING USE AND WAS REPLACED WITH A NEW ONE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8426972 ↗
• MalfunctionOct 12, 2018Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH CUFF PRESSURE. THE PRESSURED DROPPED AFTER A TIME. NO INJURY REPORTED. NO FURTHER INFORMATION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962499 ↗
• MalfunctionAug 16, 2018Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH CUFF PRESSURE. THE PRESSURED DROPPED AFTER A TIME. NO INJURY REPORTED. NO FURTHER INFORMATION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790768 ↗
• MalfunctionJul 18, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT AIR LEAKED DURING THE VENTILATION PROCESS. THE PATIENT WAS INTUBATED ON (B)(6) 2018. ON (B)(6) 2018, A FREQUENT AIR LEAK OCCURRED AND THE MEDICAL STAFF WAS REQUIRED TO ADJUST THE CUFF PRESSURE EVERY HOUR. THE PATIENT WAS CONSEQUENTLY EXTUBATED AND WATER ACCUMULATED IN THE CUFF. THE PHYSICIAN QUESTIONED IF THE WATER ACCUMULATED IN THE CUFF WOULD BE A CAUSE FOR THE AIR LEAK. THE PATIENT WAS RE-INTUBATED WITH NO PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 7697584 ↗
• MalfunctionJun 18, 2018Air Leak; Air Leak

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO: 3011270181-2018-00016 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE CUFF PRESSURE DROPPED OVER TIME. THE CUFFS REQUIRE 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 PATIENTS 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 7609306 ↗
• MalfunctionJun 18, 2018Air Leak; Air Leak

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3011270181-2018-00017 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE CUFF PRESSURE DROPPED OVER TIME. THE CUFFS REQUIRE 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 PATIENTS 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 7609294 ↗
• MalfunctionAug 18, 2017Fitting Problem; Fitting Problem

  A HALYARD HEALTH MAUDE DATABASE RECONCILIATION WAS PERFORMED ON 25-JUL-2017 THAT IDENTIFIED MAUDE REPORT NUMBER (B)(4) AS NOT IN HALYARD HEALTH'S INTERNAL SYSTEMS. THE REPORT STATED: DURING TREATMENT OF A PEDIATRIC INTENSIVE CARE PATIENT, AN ATTEMPT WAS MADE TO SUCTION THE PATIENT THROUGH A 3.0 MM ENDOTRACHEAL TUBE (ETT). IT WAS PERFORMED WITH AN 8 FR CLOSED SUCTION SYSTEM. IT APPEARED THE SECRETIONS WERE TOO THICK TO SUCTION THE PATIENT WITH A 6 FR CATHETER. THE INABILITY TO SUCTION THE PATIENT RESULTED IN A DROP IN OXYGEN AND REQUIRED REMOVAL OF THE ETT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 6803623 ↗
• MalfunctionJul 27, 2017Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE MICROCUFF TUBE BECAME OBSTRUCTED BY BLOOD AND SECRETIONS DURING SURGICAL REPAIR OF ESOPHAGEAL ATRESIA. THE ANESTHESIOLOGIST IMMEDIATELY NOTICED THE OBSTRUCTION, AND THE TUBE WAS REPLACED WITH A NEW ONE. THERE WAS NO IMPACT ON THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6746531 ↗
• MalfunctionMar 8, 2017Air Leak; Air Leak

  IT WAS REPORTED THAT THERE WAS A HOLE ON ENDOTRACHEAL TUBE NEAR WHERE THE POINT CUFF INFLATION LINE IS INSERTED TO ENDOTRACHEAL TUBE. THE PATIENT WAS INTUBATED AT 7 P.M. ON (B)(6) AND THE EVENT OCCURRED AT 1 A.M. ON (B)(6). THE LEAK OCCURRED DURING USE, SO DOCTOR CHECKED THE TUBE AND FOUND A HOLE. THE PATIENT WAS REINTUBATED WITH A NEW ENDOTRACHEAL TUBE. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6389310 ↗
• MalfunctionJan 16, 2017Partial Blockage; Partial Blockage

  THIS IS THE FOURTH OF FOUR REPORTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6253120 ↗
• MalfunctionJan 16, 2017Partial Blockage; Partial Blockage

  (B)(4) RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2017-00005 FOR THE FIRST PATIENT; REFER TO 9611594-2017-00006 FOR THE SECOND PATIENT; REFER TO 9611594-2017-00008 FOR THE FOURTH PATIENT. IT WAS REPORTED THAT THERE WAS ENDOTRACHEAL TUBE OBSTRUCTION BY VISCOUS BLOOD OR SPUTUM. THIS OCCURRED FOUR TIMES. OF THOSE FOUR TIMES, AN UNKNOWN NUMBER REQUIRED EXTUBATION AND RE-INTUBATION. THE REMAINING INCIDENTS WERE NOTED UPON SCHEDULED EXTUBATION, WITH NO RE-INTUBATION REQUIRED. THERE WERE NO INJURIES TO PATIENTS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6253095 ↗
• MalfunctionJan 16, 2017Partial Blockage; Partial Blockage

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2017-00005 FOR THE FIRST PATIENT. REFER TO 9611594-2017-00007 FOR THE THIRD PATIENT. REFER TO 9611594-2017-00008 FOR THE FOURTH PATIENT. IT WAS REPORTED THAT THERE WAS ENDOTRACHEAL TUBE OBSTRUCTION BY VISCOUS BLOOD OR SPUTUM. THIS OCCURRED FOUR TIMES. OF THOSE FOUR TIMES, AN UNKNOWN NUMBER REQUIRED EXTUBATION AND RE-INTUBATION. THE REMAINING INCIDENTS WERE NOTED UPON SCHEDULED EXTUBATION, WITH NO RE-INTUBATION REQUIRED. THERE WERE NO INJURIES TO PATIENTS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6253087 ↗
• MalfunctionJan 16, 2017Partial Blockage; Partial Blockage

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2017-00006 FOR THE SECOND PATIENT. REFER TO 9611594-2017-00007 FOR THE THIRD PATIENT. REFER TO 9611594-2017-00008 FOR THE FOURTH PATIENT. IT WAS REPORTED THAT THERE WAS ENDOTRACHEAL TUBE OBSTRUCTION BY VISCOUS BLOOD OR SPUTUM. THIS OCCURRED FOUR TIMES. OF THOSE FOUR TIMES, AN UNKNOWN NUMBER REQUIRED EXTUBATION AND RE-INTUBATION. THE REMAINING INCIDENTS WERE NOTED UPON SCHEDULED EXTUBATION, WITH NO RE-INTUBATION REQUIRED. THERE WERE NO INJURIES TO PATIENTS REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6253081 ↗