Portex 100/897/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15019315060441), received between Jun 14, 2017 and Aug 20, 2025 — classified as 1 death, 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AS THE CLINICIANS INSERTED THE TRACH TUBE INTO THE PATIENT, IT DID NOT INFLATE AND THEN BALLOON WAS LEAKING. ANOTHER ONE WAS OBTAINED FROM ICU. THE EVENT OCCURRED DURING PATIENT USE, BUT THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851100 ↗
• MalfunctionOct 18, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE. THEY TRIED SEVERAL TIMES, BUT NOTHING WORKED. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17961399 ↗
• InjuryMay 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE WHITE HUB DETACHED FROM THE TUBE 8 DAYS AFTER TRACH CHANGE. THE PATIENT DESATURATED AND HAD TO HAVE AN URGENT TRACH CHANGE DONE TO RESOLVE THE ISSUE. THIS DID NOT CAUSE ANY INJURY TO THE PATIENT. THE REPORTED LOT NUMBER WAS NOT A VALID LOT NUMBER FOR THE DEVICE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16879444 ↗
• InjuryMar 9, 2022Break; Break

  IT WAS REPORTED THAT THE INNER CANNULA PARTIALLY DISLODGED AND UNABLE TO BE SECURED INTO PLACE DESPITE RE-ATTEMPTS. PATIENT BECAME UNSTABLE, DESATURATING TO 70S. PATIENT REQUIRED AMBU-BAGGING AND DR. RETURNED TO THE BEDSIDE. DR. PERFORMED A BRONCH/TRACHEOSTOMY SWAP AND REMOVED THE OLD TRACH. THE OLD TRACH IS VISIBLY BROKEN/DEFECTIVE WITH POTENTIAL TO BECOME DISLODGED AND DESCEND FURTHER INTO THE PATIENTS AIRWAY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13715078 ↗
• InjuryFeb 16, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT TH TRACHEOSTOMY TUBE EXPERIENCED A DISCONNECTION BETWEEN THE REINFORCED SECTION AND 30MM CONNECTOR. THIS IS AN UNDETACHABLE PART OF THE TUBE, IT APPEARS TO HAVE BECOME LOOSE DUE TO HUMIDIFICATION. THE TRACHEOSTOMY TUBE HAD BEEN IN FOR 19 DAYS. THIS RESULTED DERECRUITMENT OF BOTH LUNGS AND DESATURATIONS, WHICH WAS RESOLVED BY THE PLACEMENT OF A NEW TRACHEOSTOMY TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Respiratory Insufficiency

  MAUDE report 13542107 ↗
• InjuryFeb 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED INDICATING THAT THE LOCKING MECHANISM TO A SMITHS MEDICAL PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE WAS NOTED TO MALFUNCTION; LEAVING THE TUBE SUSCEPTIBLE TO BEING DISPLACED. IT WAS REPORTED THAT THE TUBE SLIDE IN AND OUT WHILE THE PATIENT WAS BEING MECHANICALLY VENTILATED. SUBSEQUENTLY, THE TUBE WAS IMMEDIATELY REPLACED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9753993 ↗
• MalfunctionOct 28, 2018Decrease in Pressure; Device Contamination with Body Fluid; Decrease in Pressure; Device Contamination with Body Fluid

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE HAD PROBLEMS WITH THE CUFF HOLDING PRESSURE WHILE IN USE WITH A PATIENT. TWENTY DAYS AFTER INCRETION, THE TRACHEOSTOMY (TRACH) TUBE WAS REPLACED WITH ANOTHER SMITHS MEDICAL PORTEX TRACH. FOLLOWING THE CHANGE OUT, IT WAS DISCOVERED THE INITIAL TRACH PILOT BALLOON AND CUFF APPEARED TO BE FULL OF "WATER, FLUID, AND/OR SECRETIONS." NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8011148 ↗
• MalfunctionMay 10, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ON THE PORTEX® UNIPERC® TRACHEOSTOMY TUBE WAS DIFFICULT TO INFLATE. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7504722 ↗
• MalfunctionFeb 8, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBE WAS UNABLE TO BE SECURED IN PLACE. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR 11 DAYS AND THE FLANGE LOCKING DEVICE WAS WORKING UNTIL THE DATE OF THE EVENT. THE PATIENT WAS STABLE AT THE TIME OF THE EVENT. THE TRACHEOSTOMY TUBE WAS REPLACED UPON NOTICING THE FAULT. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7252501 ↗
• DeathJun 14, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING MOVEMENT OF THE PATIENT, A PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBE MOVED OUT OF THE TRACHEA. THE PATIENT REQUIRED RESUSCITATION, AND EVENTUALLY EXPIRED. ADDITIONAL INFORMATION REGARDING THE EVENT WAS REQUESTED, HOWEVER, THE REPORTER STATED THAT NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Death

  MAUDE report 6641101 ↗