Portex 198-32LRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 15019315058608), received between Apr 4, 2018 and Nov 24, 2025 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DOES NOT INFLATE. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638946 ↗
• MalfunctionMay 21, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT WAS INTUBATED ON (B)(6) 2024, A NEW BRONCHIAL DOUBLE-LUMEN INTUBATION WAS INSPECTED, AND THE AIRBAG WAS FOUND TO BE LEAKING BEFORE USE AND COULD NOT BE USED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT AS THE PRODUCT WAS INSPECTED BEFORE PATIENT USE. HOWEVER, PATIENT INFORMATION WAS PROVIDED. THERE WAS NO PATIENT HARM/ADVERSE EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359247 ↗
• MalfunctionApr 29, 2024Component Missing; Component Missing

  IT WAS STATED IN THE REPORT THAT THE, "ORIENTATION TUBE, CARRENS Y ADAPTER, SWIVEL ADAPTER, AND OTHER COMPONENTS WERE NOT ENCLOSED". THIS OCCURRED UPON REMOVAL FROM PACKAGE/CARTON, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19203360 ↗
• MalfunctionSep 22, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHEN INFLATING AND DEFLATING THE TRACHEAL CUFF AT A PRE-USE CHECK, THE CUSTOMER FELT EXTREME RESISTANCE THROUGH IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15467418 ↗
• MalfunctionSep 16, 2022Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER FOUND A SLIGHT KINK IN THE TUBE WHICH WAS BETWEEN THE BRONCHIAL CUFF AND THE TRACHEAL CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439620 ↗
• MalfunctionSep 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER FOUND DIFFICULTY IN INFLATING THE CUFF. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362796 ↗
• MalfunctionSep 4, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING PRE-USE CHECK, THE CUSTOMER NOTICED THE BRONCHIAL CUFF WAS INFLATING IN AN UNUSUAL MANNER PROBABLY BECAUSE IT WAS A LITTLE LESS FLEXIBLE THAN A NORMAL ONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353893 ↗
• MalfunctionFeb 23, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE BLUE CUFF WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586552 ↗
• MalfunctionOct 26, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE OF THE PRODUCT, DAMAGE TO THE CAP WAS FOUND, WHICH CAUSED LEAKAGE OF AIR TO OCCUR. NO PATIENT INJURY OR ADVERSE AFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12700274 ↗
• MalfunctionSep 22, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE, THE CUFF WAS FOUND DAMAGED AND LEAKING. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512368 ↗
• MalfunctionJul 16, 2021Solder Joint Fracture; Solder Joint Fracture

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOBRONCHIAL TUBES REPORTED DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE FORE END PART OF THE TUBE LOOKED MORE STRAIGHT THAN USUAL. NO PATIENT INJURY. R.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180462 ↗
• MalfunctionJun 22, 2021Gas/Air Leak; Gas/Air Leak

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12044258 ↗
• MalfunctionFeb 25, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER CONFIRMED IN A PRE-USE CHECK THAT THE PRODUCT WORKED PROPERLY. HOWEVER, AIR WAS LEAKING FROM THE CUFF DURING THE USE OF THE PRODUCT, WHICH DID NOT ALLOW HIM TO USE IT PROPERLY. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11383221 ↗
• MalfunctionJan 14, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THAT THE TIP OF THE TUBE WAS DEFORMED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11171250 ↗
• MalfunctionJan 11, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THAT THE CUFF COMPONENT OF THE PORTEX ENDOBRONCHIAL TUBE WAS BENT. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11149099 ↗
• MalfunctionJul 10, 2020Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOBRONCHIAL TUBE IMMEDIATELY UPON THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE SLIP JOINT WAS PARTIALLY DEFORMED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10258247 ↗
• MalfunctionMay 6, 2020Material Deformation; Material Deformation

  INVESTIGATION COMPLETED ON A SMITHS MEDICAL INTUBATION/PORTEX ENDOBRONCHIAL TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10029171 ↗
• InjuryJan 31, 2020Material Too Rigid or Stiff; Inadequacy of Device Shape and/or Size; Material Too Rigid or Stiff; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX ENDOBRONCHIAL TUBE WAS IN USE WITH A PATIENT AT THE HOSPITAL. THE PATIENT WAS REPORTED TO HAVE AN UNSPECIFIED PLEURAL EFFUSION AND IMMEDIATELY UPON PLACEMENT HAD DIFFICULTY HANDLING AND PASSING THE TUBE DUE TO ITS CURVATURE AND NOTED "HARDER MATERIAL". SUBSEQUENTLY, ANOTHER TUBE OF THE SAME BRAND WAS USED. THE PATIENT HAD NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9655278 ↗
• MalfunctionDec 5, 2019Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL ENDOTRACHEAL TUBE WAS IN USE WITH A PATIENT, THE DEVICE WAS NOTED TO BE LEAKING AIR FROM THE BRONCHIAL CUFF. THE CUFF WAS NOTED TO BE DAMAGED. NO PATIENT INJURY RESULTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418746 ↗
• MalfunctionJun 11, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THE ORIENTATION OF THE TUBE'S FORE END PART WAS DIFFERENT FROM THAT OF OTHER NORMAL ONES. ALSO, THE ENTIRE PART OF THE TUBE WAS FOUND EXCESSIVELY CURVED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689889 ↗
• MalfunctionJun 11, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT IMMEDIATELY AFTER STARTING TO USE THE PRODUCT, THERE WAS A SUSPECTED AIR LEAK FROM THE SWIVEL ADAPTER. AFTER THE CUSTOMER REMOVED THE ADAPTER, THE AIR LEAK WAS NO LONGER OBSERVED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689872 ↗
• InjuryApr 5, 2019Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED INDICATING THAT THE FORE END OF A SMITHS MEDICAL PORTEX ENDOBRONCHIAL DOUBLE LUMEN TUBE WAS BENT. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8488659 ↗
• MalfunctionNov 20, 2018Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® ENDOBRONCHIAL TUBE WAS KINKED WHILE IN USE WITH THE PATIENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8092591 ↗
• MalfunctionApr 4, 2018Filling Problem; Filling Problem

  IT WAS REPORTED THAT DURING USE OF A PORTEX® ENDOBRONCHIAL DOUBLE LUMEN, THE CUSTOMER COULD NOT PERFORM A SINGLE-LUNG VENTILATION BECAUSE THE BRONCHIAL CUFF (A BLUE CUFF) WAS NOT PROPERLY SEALED. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396091 ↗