Portex 101/810/090CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15019517076325), received between Apr 16, 2021 and Mar 3, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (3 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.

• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE PLASTIC THAT HOLDS PATIENT'S "NECK TIE" IN PLACE HAD SNAPPED CAUSING THE TRACHEOSTOMY TO COME LOOSE. THE TRACHEOSTOMY BROKE AT THE SITE WHERE THE FABRIC NECK TIE WRAPS AROUND THE SOFT PLASTIC OF THE BASE PLATE OF THE FLANGE. THE BROKEN TRACHEOSTOMY WAS REMOVED AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503018 ↗
• MalfunctionMar 3, 2026Break

  IT WAS REPORTED THAT THE PLASTIC THAT HOLDS PATIENT'S "NECK TIE" IN PLACE HAD SNAPPED CAUSING THE TRACHEOSTOMY TO COME LOOSE. THE TRACHEOSTOMY BROKE AT THE SITE WHERE THE FABRIC NECK TIE WRAPS AROUND THE SOFT PLASTIC OF THE BASE PLATE OF THE FLANGE. THE BROKEN TRACHEOSTOMY WAS REMOVED AND REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501482 ↗
• MalfunctionJun 25, 2024Deflation Problem; Leak/Splash; Deflation Problem; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE HAD A LEAK AFTER INSERTION. THE PATIENT COULD BREATH NORMALLY WHOSE CANNULA BECAME MORE SLIMY. THERE WAS PATIENT INVOLVEMENT BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610751 ↗
• MalfunctionMar 18, 2024Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE PATIENT HAD THE TRACHEOSTOMY CANNULA EXCHANGED ON FOR A "N°9 ENDOCANNULA WITH BALLOON," BUT IT DID NOT KEEP THE CUFF INFLATED. IT WAS INFORMED THAT IT WAS "REPAIRED DURING THE PROCEDURE". THERE IS NO SAMPLE AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVED. THERE WAS NO HARM OR ADVERSE EVENT REPORTED. FURTHER DETAILS ON THE "REPAIR" HAVE NOT BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924314 ↗
• InjuryApr 17, 2021Obstruction of Flow; Obstruction of Flow

  WITH A TOTAL OF 3 TRACHEAL CANNULAE, IT WAS NOT POSSIBLE TO PERFORM A COMPLETE BLOCK WITH THE HELP OF THE CUFF DURING USE. ONLY AFTER THE CUFF WAS COMPLETELY UNBLOCKED WAS IT POSSIBLE TO PERFORM ANOTHER BLOCKAGE, BUT THIS CONDITION DID NOT LAST. FURTHERMORE, THERE WAS FLUID IN THE CUFF BALLOON AND THE SUPPLY LINE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Airway Obstruction; Insufficient Information

  MAUDE report 11682908 ↗
• InjuryApr 16, 2021Obstruction of Flow; Obstruction of Flow

  WITH A TOTAL OF 3 TRACHEAL CANNULAE, IT WAS NOT POSSIBLE TO PERFORM A COMPLETE BLOCK WITH THE HELP OF THE CUFF DURING USE. ONLY AFTER THE CUFF WAS COMPLETELY UNBLOCKED WAS IT POSSIBLE TO PERFORM ANOTHER BLOCKAGE, BUT THIS CONDITION DID NOT LAST. FURTHERMORE, THERE WAS FLUID IN THE CUFF BALLOON AND THE SUPPLY LINE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11682879 ↗
• InjuryApr 16, 2021Obstruction of Flow; Obstruction of Flow

  WITH A TOTAL OF 3 TRACHEAL CANNULAE, IT WAS NOT POSSIBLE TO PERFORM A COMPLETE BLOCK WITH THE HELP OF THE CUFF DURING USE. ONLY AFTER THE CUFF WAS COMPLETELY UNBLOCKED WAS IT POSSIBLE TO PERFORM ANOTHER BLOCKAGE, BUT THIS CONDITION DID NOT LAST. FURTHERMORE, THERE WAS FLUID IN THE CUFF BALLOON AND THE SUPPLY LINE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Airway Obstruction; Insufficient Information

  MAUDE report 11682878 ↗