Portex 100/166/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 15019315054099), received between Mar 14, 2017 and Jan 6, 2026 — classified as 6 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (12 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Deflation Problem

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE INFLATOR LINE WAS DEFLATED. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973950 ↗
• MalfunctionDec 29, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT IN THE OPERATING ROOM, THE ANESTHESIOLOGY ATTENDING PHYSICIAN PERFORMED INTUBATION TUBE WITH THE MACINTOSH LARYNGOSCOPE AND POSTOPERATIVELY IN THE ICU, THE VENTILATOR TRIGGERED A LOW INSPIRATORY PRESSURE ALARM. PER REPORTER, A CUFF LEAK WAS CONFIRMED, AND THE DEVICE WAS REPLACED. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919003 ↗
• MalfunctionOct 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED THAT THERE WAS A CUFF LEAK AND IT WAS RESOLVED AFTER SWITCHING THE TUBE. THE EVENT OCCURRED DURING PATIENT USE AT THE FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367590 ↗
• MalfunctionJun 6, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT AFTER INTUBATION, DURING THE CUFF LEAK PRIOR TO EXTUBATION, THE AIR IN THE CUFF COULD NOT BE DELATED. THE PHYSICIAN CUT THE INFLATION LINE AND ATTEMPTED TO DEFLATE THE AIR IN THE CUFF IN ORDER TO PROCEED WITH EXTUBATION. THE EVENT OCCURRED DURING USE AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22159708 ↗
• MalfunctionMay 30, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE WHILE TESTING. THE ISSUE WAS RESOLVED BY USING A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22116420 ↗
• MalfunctionApr 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK FROM THE CUFF. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858619 ↗
• MalfunctionFeb 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK FROM THE CUFF. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428481 ↗
• MalfunctionJan 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE WHILE TESTING. THE ISSUE WAS RESOLVED BY USING A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149833 ↗
• MalfunctionJan 14, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF DID NOT COMPLETELY INFLATE WHILE TESTING (LEAK). STEPS TAKEN TO RESOLVE THE ISSUE WAS TO USE A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149361 ↗
• InjuryJan 14, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS LEAKING AFTER ABOUT FIFTEEN MINUTES AFTER INTUBATION. THE ISSUE WAS RESOLVED BY CHANGING TO A NEW PRODUCT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21148899 ↗
• MalfunctionJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INFLATION LINE WAS DETACHED FROM THE TUBE AFTER INTUBATED FOR FIFTEEN MINUTES. STEPS TAKEN TO RESOLVE THE ISSUE WAS TO USE A NEW ONE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147970 ↗
• MalfunctionNov 8, 2024Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR FOUND THAT THE CUFF WAS LEAKING AFTER BEING INTUBATED FOR 30 MINUTES. THE ROOT CAUSE WAS IDENTIFIED, AND THEY REMOVED AND FOUND THE CUFF HAD COLLAPSED. THE ISSUE WAS ESCALATED; THE PATIENT HAD TO BE REINTUBATED THREE TIMES. THIS OCCURRED WITH 5 PRODUCTS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640554 ↗
• InjurySep 24, 2024Decrease in Pressure; Gas/Air Leak; Decrease in Pressure; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF PRESSURE DECREASED, THE CUFF WAS LEAKING AT THE PILOT BALLOON WHILE OPERATION WAS IN PROCESS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20293197 ↗
• MalfunctionJul 24, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKED FROM THE CUFF. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19821879 ↗
• MalfunctionMay 9, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE CUFF CANNOT BE KEPT "CONSTANT" IN THE OPERATING ROOM. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279748 ↗
• MalfunctionSep 28, 2023Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE TUBE CUFF WAS CHECKED FOR AIR LEAKAGE BEFORE USE, AND THERE WERE NO PROBLEMS. AFTER INTUBATING THE PATIENT AND INJECTING AIR, THE PILOT BALLOON DID NOT INFLATE, AND THE CUSTOMER DETERMINED THAT THERE WAS AN AIR LEAK. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17839738 ↗
• MalfunctionOct 13, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN INFLATING THE DEICE BALLOON, IT WAS DISCOVERED THERE WAS A HOLE IN IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597535 ↗
• InjuryAug 30, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT AFTER PATIENT INTUBATION A VENTILATION ISSUE WAS OBSERVED. AFTER EXAMINATION VIA FIBROSCOPY, VISIBLE FOLDING OF THE INTUBATION TUBE WAS FOUND TO BE PREVENTING VENTILATION. TUBE WAS IN PLACE FOR FOURTEEN DAYS. REMOVAL OF THE TUBE WITH GUIDE AND REINTUBATION WITH A NEW TUBE RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022 STATING NO CLINICAL CONSEQUENCE TO THE PATIENT WAS OBSERVED. PREMATURE TUBE CHANGE HAD TO TAKE PLACE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 STATING THE TUBE WAS BENT AROUND AND BETWEEN THE BASE OF THE TONGUE AND THE PHARYNX ABOUT IN THE MIDDLE OF THE TUBES. INCIDENT OCCURRED WITH THREE (3) PATIENTS AFTER FOURTEEN (14) DAYS (PATIENT 1), NINE (9) DAYS (PATIENT 2) AND ONE (1) DAY (PATIENT 3). INTUBATION WAS NOT DIFFICULT FOR ALL THREE PATIENTS AND UNDER DIRECT LARYNGOSCOPY. THE PATIENTS WERE IN INTENSIVE CARE UNIT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15322268 ↗
• InjuryAug 30, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT AFTER PATIENT INTUBATION A VENTILATION ISSUE WAS OBSERVED. AFTER EXAMINATION VIA FIBROSCOPY, VISIBLE FOLDING OF THE INTUBATION TUBE WAS FOUND TO BE PREVENTING VENTILATION. TUBE WAS IN PLACE FOR FOURTEEN DAYS. REMOVAL OF THE TUBE WITH GUIDE AND REINTUBATION WITH A NEW TUBE RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON 4-AUG-2022 STATING NO CLINICAL CONSEQUENCE TO THE PATIENT WAS OBSERVED. PREMATURE TUBE CHANGE HAD TO TAKE PLACE. ADDITIONAL INFORMATION RECEIVED ON 16-AUG-2022 STATING THE TUBE WAS BENT AROUND AND BETWEEN THE BASE OF THE TONGUE AND THE PHARYNX ABOUT IN THE MIDDLE OF THE TUBES. INCIDENT OCCURRED WITH THREE (3) PATIENTS AFTER FOURTEEN (14) DAYS (PATIENT 1), NINE (9) DAYS (PATIENT 2) AND ONE (1) DAY (PATIENT 3). INTUBATION WAS NOT DIFFICULT FOR ALL THREE PATIENTS AND UNDER DIRECT LARYNGOSCOPY. THE PATIENTS WERE IN INTENSIVE CARE UNIT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15322257 ↗
• InjuryAug 30, 2022Material Invagination; Material Invagination

  IT WAS REPORTED THAT AFTER PATIENT INTUBATION A VENTILATION ISSUE WAS OBSERVED. AFTER EXAMINATION VIA FIBROSCOPY, VISIBLE FOLDING OF THE INTUBATION TUBE WAS FOUND TO BE PREVENTING VENTILATION. TUBE WAS IN PLACE FOR FOURTEEN DAYS. REMOVAL OF THE TUBE WITH GUIDE AND REINTUBATION WITH A NEW TUBE RESOLVED THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022 STATING NO CLINICAL CONSEQUENCE TO THE PATIENT WAS OBSERVED. PREMATURE TUBE CHANGE HAD TO TAKE PLACE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 STATING THE TUBE WAS BENT AROUND AND BETWEEN THE BASE OF THE TONGUE AND THE PHARYNX ABOUT IN THE MIDDLE OF THE TUBES. INCIDENT OCCURRED WITH THREE (3) PATIENTS AFTER FOURTEEN (14) DAYS (PATIENT 1), NINE (9) DAYS (PATIENT 2) AND ONE (1) DAY (PATIENT 3). INTUBATION WAS NOT DIFFICULT FOR ALL THREE PATIENTS AND UNDER DIRECT LARYNGOSCOPY. THE PATIENTS WERE IN INTENSIVE CARE UNIT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15321446 ↗
• MalfunctionDec 29, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT AN INTUBATION WAS DIFFICULT WHILE USING A NEW TYPE OF PROBE RANGE. THE CUSTOMER REPORTED THAT THE DEVICE WAS TOO FLEXIBLE, THE DEVICE WAS "TWISTED" ALONG THE ESCHMANN MANDREL WHILE USING IT TO PASS THE VOCAL CORDS. DELAYED PATIENT CARE CAUSING PROLONGATION OF HOSPITALIZATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114785 ↗
• MalfunctionMay 25, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PRODUCT WAS LEAKING AIR. THERE WAS NO PATIENT INJURY REPORTED. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11881657 ↗
• MalfunctionMay 13, 2021Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE DEVICE WAS IN USE AND A LEAK WAS FOUND AT A CRACKED AREA OF THE TUBE. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11817282 ↗
• MalfunctionApr 9, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® ENDOTRACHEAL TUBE WAS NOTED TO NOT MAINTAIN AIR PRESSURE AND A LEAKAGE WAS CONFIRMED. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946664 ↗
• MalfunctionJan 13, 2020Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY AFTER PLACEMENT OF A SMITHS MEDICAL PORTEX® ENDOTRACHEAL TUBE INTO A PATIENT, THE CUFF WAS TORN. THE PRODUCT WAS REMOVED AND RETURNED FOR ANALYSIS. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584435 ↗