Portex 100/166/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15019315054082), received between Apr 17, 2017 and Sep 16, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792876 ↗
• MalfunctionApr 15, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PILOT BALLOON INFLATED DURING PRIMING, BUT NO AIR ENTERED THE LINE NOR CUFF. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105758 ↗
• MalfunctionMay 4, 2023Unexpected Color; Unexpected Color

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, A STAIN WAS FOUND ON THE TUBE LUMEN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873013 ↗
• MalfunctionNov 15, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NURSE FOUND THE CUFF LEAKING WHILE TESTING BEFORE USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799221 ↗
• MalfunctionDec 18, 2020Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS UNABLE TO BE INFLATED AT THE CUFF DURING A PRE-USE CHECK. IN ADDITION, THE SHAPE OF THE INFLATED WAS DIFFERENT FROM USUAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11041355 ↗
• MalfunctionDec 18, 2020Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS UNABLE TO BE INFLATED AT THE CUFF DURING A PRE-USE CHECK. IN ADDITION, THE SHAPE OF THE INFLATED WAS DIFFERENT FROM USUAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11039799 ↗
• MalfunctionDec 17, 2020Gas/Air Leak; Gas/Air Leak

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11030435 ↗
• MalfunctionSep 17, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE PILOT BALLOON TO A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE WAS OBSERVED TO BE LEAKING. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10547287 ↗
• InjuryJan 13, 2020Inflation Problem; Inflation Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9584439 ↗
• MalfunctionSep 10, 2018Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS IN USE WITH PATIENT. THE REPORTER STATED THE DEVICE LEAKED AIR NEAR THE CUFF CONNECTION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7859892 ↗
• MalfunctionApr 17, 2017Kinked; Kinked

  IT WAS FURTHER REPORTED THAT THE ENDOTRACHEAL TUBE KINKED AFTER BEING PATIENT USE FOR 10 HOURS. THE ENDOTRACHEAL TUBE WAS REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6498128 ↗