Portex 100/897/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15019315060434), received between Jun 5, 2017 and Aug 21, 2026 — classified as 1 death, 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379893 ↗
• MalfunctionJul 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE TRACHEOSTOMY TUBE DID NOT HOLD THE TUBE SECURELY IN PLACE. ON SEVERAL OCCASIONS, THE TUBE SLIPPED OUTWARD, REQUIRING READJUSTMENT AND REPOSITIONING. THIS TRACHEOSTOMY TUBE WAS INSERTED ON (B)(6) 2026. ON (B)(6) 2026, IT WAS NOTED THAT THE TRACHEOSTOMY TUBE HAD SLIPPED OUT AND THAT A GREATER PORTION OF THE TUBE WAS VISIBLE OUTSIDE THE WING. AN ENT PHYSICIAN REPOSITIONED THE TUBE BY ADVANCING IT 2¿3 CM. IT WAS OBSERVED THAT THE TUBE WAS NOT FULLY SECURED BUT APPEARED TO BE HELD MORE FIRMLY WHEN THE BLUE LOCKING MECHANISM WAS PRESSED COMPLETELY TO THE BOTTOM RATHER THAN ONLY TO THE SAME LEVEL AS THE WHITE PLASTIC COMPONENT. ON (B)(6) 2026, IT WAS AGAIN OBSERVED THAT THE TUBE HAD MIGRATED RELATIVE TO THE WING. THE TUBE WAS REPOSITIONED DOWNWARD. ON (B)(6) 2026, THE TUBE HAD ONCE AGAIN MOVED UPWARD RELATIVE TO THE WING BY APPROXIMATELY 2¿3 CM, AND IT BECAME EVIDENT THAT THE LOCKING MECHANISM WAS NOT FUNCTIONING PROPERLY. THE DEVICE WAS REPLACED WITH A NEW PORTEX UNIPERC TRACHEOSTOMY TUBE FROM A DIFFERENT LOT NUMBER. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY. HOWEVER, SEVERAL DISTRESSING EPISODES OCCURRED DURING WHICH BREATHING FUNCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25703610 ↗
• MalfunctionMar 25, 2026Gas/Air Leak

  IT WAS REPORTED THAT UPON INSERTION A LEAK WAS DISCOVERED. THE LEAK WAS FOUND AT THE TOP OF THE TRACHEOSTOMY TUBE AFTER REMOVAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688632 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS LEAKING AND COULD NOT INFLATE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24239091 ↗
• DeathJul 21, 2025Improper or Incorrect Procedure or Method; Installation-Related Problem; Improper or Incorrect Procedure or Method; Installation-Related Problem

  IT WAS REPORTED THAT THE DEVICE BECAME DISPLACED FOLLOWING SURGICAL INSERTION IN ONE OF THE ICU PATIENTS. THE MECHANISM/'CLIP' USED TO SECURE THE TRACHEOSTOMY TUBE ITSELF TO THE FLANGE CAUSED A POTENTIAL SAFETY CONCERN. THE TRACHEOSTOMY WAS MISTAKENLY INSERTED UPSIDE DOWN, WITH THE "CLIP" FACING UPWARDS. THIS RESULTED IN IT BECOMING KNOCKED OPEN WHEN THE PATIENT WAS MOVED. THE TRACHEOSTOMY BECAME DISPLACED AND THE PATIENT RAPIDLY DESATURATED DIFFICULTIES REPLACING IT THROUGH A FRESH STOMA. THE TRACHEOSTOMY BECAME DISPLACED THE MORNING AFTER IT WAS SURGICALLY PLACED ON (B)(6) 2025. IT WAS ALSO DIFFICULT TO RE-INTUBATE HER, BUT SURGICAL ASSISTANCE WAS ON HAND TO PLACE A SMALL (SIZE 6) ENDOTRACHEAL TUBE THROUGH THE TRACHEOSTOMY STOMA PRIOR TO IT BEING FORMALLY REPLACED IN THEATRE. THE PATIENT SUBSEQUENTLY DIED BUT HER DEATH WAS NOT DIRECTLY RELATED TO THE DISPLACED TRACHEOSTOMY. THE STATUS OF THE EVENT IS RESOLVED. THERE WAS PATIENT INVOLVEMENT AND ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554746 ↗
• MalfunctionNov 1, 2023Disconnection; Loose or Intermittent Connection; Connection Problem; Disconnection; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE IS NOT BEING HELD SECURELY BY THE FLANGE. DESPITE BEING LOCKED, THE TUBE SLIPPED THROUGH AND ADVANCED 3.5CM INTO THE PATIENT'S AIRWAY. ALSO NOTED THAT THE CONNECTOR AT THE END OF THE TRACHEOSTOMY TUBE (TO CONNECT TO CIRCUIT) IS LOOSE AND DISCONNECTS EASILY. NO INJURY REPORTED. PATIENT INVOLVEMENT. PATIENT INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047885 ↗
• InjuryOct 19, 2023Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2023, A TRACHEOSTOMY TUBE WAS PLACED IN THE PATIENT DURING AN OR PROCEDURE. ON (B)(6) 2023, THE BEDSIDE RRT NOTICED THAT THE WHITE ADAPTER OF THE TRACH TUBE WAS LOOSE AND DETACHING FROM THE TRACH TUBE (CLEAR PLASTIC TRACH TUBE SLID OFF OF TRACH ADAPTOR). MULTIPLE ATTEMPTS WERE MADE TO REATTACH THE ADAPTER BUT IT WOULD NOT STAY IN PLACE. BECAUSE THE PATIENT REQUIRED MECHANICAL VENTILATION, THE RRT HAD TO STAY AT THE BEDSIDE TO HOLD THE TRACH AND ADAPTER TOGETHER UNTIL HELP ARRIVED TO CHANGE OUT THE TUBE. THE INTENSIVIST WAS PROMPTLY NOTIFIED OF THE SITUATION AND ARRANGEMENT WERE MADE TO EXCHANGE THE TUBE UNDER VISUALIZATION WITH A FIBEROPTIC BRONCHOSCOPE. THE DEFECTIVE TRACH WAS REMOVED OVER THE BRONCH TO ENSURE AIRWAY PATENCY AND INTEGRITY. ONCE THIS WAS ESTABLISHED, A NEW TRACHEOSTOMY TUBE FROM A DIFFERENT MANUFACTURER WAS INSERTED WITHOUT INCIDENT AND PLACEMENT WAS ASSESSED AND VERIFIED WITH BRONCHOSCOPE. "NO SERIOUS HARM" REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17966132 ↗
• MalfunctionNov 18, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED THAT AFTER EIGHT HOURS IN USE, A SMITHS MEDICAL UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY HAD AN INSUFFICIENT SEAL. AS A RESULT, THE TUBE WAS WITHDRAWN AND A NEW TUBE WAS INSERTED. A BULGE WAS NOTED ON THE TUBE THAT WAS WITHDRAWN. NO ADVERSE EFFECTS OCCURRED,

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9336970 ↗
• MalfunctionJun 5, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE "PIPE" CONNECTING THE SYRINGE TO THE BALLOON OF A PORTEX® UNIPERC® ADJUSTABLE FLANGE EXTENDED-LENGTH TRACHEOSTOMY TUBE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6612183 ↗