Portex 101/860/085Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15019517077940), received between Nov 13, 2023 and Jun 29, 2026 — classified as 2 injuries, 5 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE BLUSELECT 8.5 SUCTIONAID TRACHEOSTOMY TUBES DEVELOPED HOLES, RESULTING IN A LEAK THAT WAS OBSERVED AFTER APPROXIMATELY ONE DAY OF USE. THE DAMAGE WAS IDENTIFIED DURING REPLACEMENT OF THE TRACHEOSTOMY TUBE. THERE WERE PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED, THE DAMAGED TRACHEOSTOMY TUBES COULD RESULT IN AN AIR LEAK, COMPROMISE VENTILATION, AND POTENTIALLY AFFECT THE PATIENT IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659118 ↗
• MalfunctionJun 29, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE BLUSELECT 8.5 SUCTIONAID TRACHEOSTOMY TUBES DEVELOPED HOLES, RESULTING IN A LEAK THAT WAS OBSERVED AFTER APPROXIMATELY ONE DAY OF USE. THE DAMAGE WAS IDENTIFIED DURING REPLACEMENT OF THE TRACHEOSTOMY TUBE. THERE WERE PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED, THE DAMAGED TRACHEOSTOMY TUBES COULD RESULT IN AN AIR LEAK, COMPROMISE VENTILATION, AND POTENTIALLY AFFECT THE PATIENT IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25659113 ↗
• MalfunctionJun 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT WHEN AIR WAS INJECTED INTO THE CUFF, IT IMMEDIATELY LEAKED OUT DURING VENTILATION AT PATIENT HOME. THERE WAS PATIENT INVOLVEMENT, WITH NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25492242 ↗
• MalfunctionMar 11, 2026Gas/Air Leak

  THE CUSTOMER RETURNED THE DEVICE STATING, ¿THE CUFF WAS DAMAGED¿; DURING DEVICE EVALUATION A LEAK WAS FOUND CAUSED BY AN ASSEMBLY ERROR DURING MANUFACTURING. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24568527 ↗
• MalfunctionFeb 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PILOT BALLOON HAD COME OFF. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269069 ↗
• InjuryNov 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE INSERTED TO THE PATIENT, BY THE DOCTOR IN THE OPERATING ROOM WAS DEFLATED AFTER INSERTION. SUBSEQUENTLY, DEVICE WITH WHICH IT WAS EXCHANGED IN THE DEPARTMENT BY THE DOCTOR ALSO HAD A CUFF FAILURE. THE EXACT "FAILURE" WAS NOT DESCRIBED. NO PATIENT HARM. A1: ONE PATIENT, TWO PRODUCT MALFUNCTIONS. (B)(6) REPRESENT THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18135001 ↗
• InjuryNov 13, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE DEVICE INSERTED TO THE PATIENT BY THE DOCTOR IN THE OPERATING ROOM WAS DEFLATED AFTER INSERTION. SUBSEQUENTLY, THE DEVICE WITH WHICH IT WAS EXCHANGED IN THE DEPARTMENT BY THE DOCTOR ALSO HAD A CUFF FAILURE. NO PATIENT HARM. A1: ONE PATIENT, TWO PRODUCT MALFUNCTIONS. (B)(6) BOTH REPRESENT THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18125095 ↗