Portex 100/870/070CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019315104848), received between Sep 14, 2020 and Dec 8, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS STATED IN THE REPORT THAT A 76-YEAR-OLD MALE PATIENT BORN ON (B)(6) 1949 UNDERWENT SURGERY USING A TRACHEOSTOMY TUBE AND ITS ACCESSORIES. DURING THE PROCEDURE, THE DOCTOR FOUND THAT THE AIRBAG WAS DAMAGED AND LEAKING AIR, AND IT WAS IMMEDIATELY REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23749453 ↗
• MalfunctionJun 27, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKED DURING TESTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14838005 ↗
• InjurySep 14, 2020Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE WAS SPONTANEOUSLY DEFLATING. SUBSEQUENTLY, THE TRACH TUBE WAS CHANGED OUT WITH A NEW ONE. THREE WEEKS LATER, THE CUFF SPONTANEOUSLY DEFLATED AGAIN. A COMBI STOPPER WAS PUT IN THE PILOT TUBE AND THE PRESSURE HELD. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10531895 ↗
• InjurySep 14, 2020Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE WAS SPONTANEOUSLY DEFLATING. SUBSEQUENTLY, THE TRACH TUBE WAS CHANGED OUT WITH A NEW ONE. THREE WEEKS LATER, THE CUFF SPONTANEOUSLY DEFLATED AGAIN. A COMBI STOPPER WAS PUT IN THE PILOT TUBE AND THE PRESSURE HELD. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10531868 ↗