Portex 100/870/090CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019315104886), received between Oct 24, 2022 and Dec 23, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 23, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PATIENT USE, THE SUCTION AID PORT OF THE TRACHEOSTOMY TUBE HAD SPLIT OR CRACKED. IT WAS ALSO NOTED THAT THE CUFF FAILED DUE TO A HOLE IN THE PILOT BALLOON. THE TUBE WAS REPLACED WITHOUT ISSUE, AND NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23883919 ↗
• MalfunctionOct 30, 2024Crack; Crack

  IT WAS REPORTED THAT AFTER TWENTY DAYS AFTER THE SURGERY AND USE OF THE CANNULA, THE ENDOCANNULA (THE REMOVABLE ONE) SIMPLY CRACKED. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569374 ↗
• MalfunctionNov 21, 2022Defective Component; Material Split, Cut or Torn; Defective Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUBGLOTTIC SUCTION DOESN'T WORK. ADAPTER IS TORN. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834831 ↗
• MalfunctionOct 24, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT MAKING STOPPER IN TQT WITHOUT INTERMEDIARY, FOR BECAUSE TO THE SAME IS DAMAGED. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663281 ↗