Portex 100/897/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 15019315107207), received between Mar 21, 2017 and Apr 15, 2026 — classified as 13 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 2026Leak/Splash; Ventilation Problem in Device Environment

  IT WAS REPORTED THAT THERE WERE CUFF LEAKS INVOLVING PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBES, WITH ONE OCCURRING WITHIN 24 HOURS OF A TUBE EXCHANGE. ON EXAMINATION, THERE WAS NO OBVIOUS AIR LEAK DETECTED WHEN THE TUBE WAS FULLY SUBMERGED UNDER WATER AT A CUFF PRESSURE OF 30 CMH2O. HOWEVER, THEY DID OBSERVE A DROP IN CUFF PRESSURE FROM 30 CMH2O TO 28 CMH2O OVER A 30-MINUTE PERIOD. ESTABLISHED ARTIFICIAL AIRWAY WAS BEING ADMINISTERED OR PERFORMED. THERE WAS DELAY IN THERAPY. IT WAS NOT REPORTED TO REGULATORY AUTHORITY. THE EVENT INVOLVED DEATH OR SERIOUS DETERIORATION OF A PERSON. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM OR ADVERSE EVENT REPORTED. PATIENT DESATURATED PRIOR TO AND DURING TRACHEOSTOMY CHANGEOVER. PATIENT RECOVERED WITHOUT MORBIDITY OR MORTALITY.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24883416 ↗
• InjuryApr 15, 2026Leak/Splash; Ventilation Problem in Device Environment

  IT WAS REPORTED THAT THERE WERE CUFF LEAKS INVOLVING PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBES, WITH ONE OCCURRING WITHIN 24 HOURS OF A TUBE EXCHANGE. ON EXAMINATION, THERE WAS NO OBVIOUS AIR LEAK DETECTED WHEN THE TUBE WAS FULLY SUBMERGED UNDER WATER AT A CUFF PRESSURE OF 30 CMH2O. HOWEVER, THEY DID OBSERVE A DROP IN CUFF PRESSURE FROM 30 CMH2O TO 28 CMH2O OVER A 30-MINUTE PERIOD. THE CUFF WAS INFLATED USING A PORTEX MANOMETER. ESTABLISHED ARTIFICIAL AIRWAY WAS BEING ADMINISTERED OR PERFORMED. THERE WAS DELAY IN THERAPY. IT WAS NOT REPORTED TO REGULATORY AUTHORITY. THE EVENT INVOLVED DEATH OR SERIOUS DETERIORATION OF A PERSON. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM OR ADVERSE EVENT REPORTED. PATIENT DESATURATED PRIOR TO AND DURING TRACHEOSTOMY CHANGEOVER. PATIENT RECOVERED WITHOUT MORBIDITY OR MORTALITY.

  Patient problems: Low Oxygen Saturation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24882546 ↗
• MalfunctionJan 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF APPEARED TO BE LEAKING AND WOULDN¿T STAY INFLATED ON TWO OCCASIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143778 ↗
• MalfunctionJan 16, 2024Loose or Intermittent Connection; Material Too Soft/Flexible; Loose or Intermittent Connection; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE WHITE END OF THE DEVICE HAD BECOME LOOSE AND WAS NOT SECURE. THE ENTRANCE TO THE TRACHEOSTOMY APPEARED VERY SOFT. THE DEVICE WAS IN USE ON THE PATIENT AT THE TIME OF DISCOVERING THE ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18518570 ↗
• MalfunctionAug 25, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE BLUE LATCH THAT LOCKS THE TRACH TUBE IN PLACE DID NOT WORK. TRACH HAD TO BE REMOVED FROM THE PATIENT AND A NEW ONE OPENED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293260 ↗
• MalfunctionJul 22, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING PRE-USE INSPECTION, CUFF LEAKAGE WAS DETECTED WITHOUT EXTERNAL INFLUENCE, I.E.. THE CUFF WAS BROKEN ALREADY WHEN THE TUBE WAS TAKEN OUT OF ITS PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15089071 ↗
• MalfunctionJul 22, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING PRE-USE INSPECTION, CUFF LEAKAGE WAS DETECTED WITHOUT EXTERNAL INFLUENCE, I.E. THE CUFF WAS BROKEN ALREADY WHEN THE TUBE WAS TAKEN OUT OF ITS PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15087975 ↗
• MalfunctionMay 19, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE PRODUCT IS NOT SEALED AND STERILE UPON OPENING. THE WHITE PAPER ON THE INNER PACKAGING WAS COMPLETELY MISSING. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14437537 ↗
• InjuryJul 22, 2021Separation Failure; Separation Failure

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC WAS INVOLVED IN INCIDENT WHERE AIRWAY OBSTRUCTION OCCURRED. A SWAB WAS RETAINED INSIDE THE TRACHEOSTOMY TUBE AND DISLODGED INTO THE PATIENTS AIRWAY WITH SUCTION TUBING, THETUBE IS OPAQUE AND THE SWAB NOT SEEN.PATIENT REQUIRED SEDATION AND BRONCHOSCOPE TO REMOVE THE SWAB FROM THE BRONCHUS. THIS IS NOT DESCRIBING MALFUNCTION OF THE DEVICE, HOWEVER THE DEVICE WAS INVOLVED IN THE SERIOUS INJURY THAT OCCURRED WHEN SWAB DETACHED BY CAREGIVER AND DISLODGED INTO AIRWAY.

  Patient problems: Airway Obstruction

  MAUDE report 12214883 ↗
• InjuryApr 15, 2021Gel Leak; Gel Leak

  NO PRODUCT WAS RETURNED. SME SIGNED OFF WITH SUMMARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675629 ↗
• InjuryApr 15, 2021Gel Leak; Gel Leak

  RUPTURED CUFF ON POSTERIOR ASPECT. FROM MHRA REPORT: AUDIBLE LEAK HEARD BY STAFF NURSE REFERRED TO ENT FOLLOWING DISCUSSION WITH CONSULTANT ? CUFF ISSUE. NO HARM TO PATIENT. SCHEDULED TUBE CHANGE IN THEATRE BY ENT SURGEONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670819 ↗
• InjuryApr 11, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC WAS LEAKING FROM THE CHANNEL BY PILOT BALLOON AND CUFF. WEAK OCCURRED DURING PATIENT USAGE AS TIDAL VOLUMES WAS NOT BEING ACHIEVED. ENT WAS CONSULTED AND URGENT ASSESSMENT WAS MADE FOR TRACHEOTOMY TUBE EXCHANGE. SIZE 8 WAS EXCHANGED AND CUFF PRESSURE CHECKED WITH NO LEAK.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11646683 ↗
• InjuryApr 11, 2021Gel Leak; Gel Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC WAS LEAKING FROM THE CHANNEL BY PILOT BALLOON AND CUFF. WEAK OCCURRED DURING PATIENT USAGE AS TIDAL VOLUMES WAS NOT BEING ACHIEVED. ENT WAS CONSULTED AND URGENT ASSESSMENT WAS MADE FOR TRACHEOTOMY TUBE EXCHANGE SIZE 8 WAS EXCHANGED AND CUFF PRESSURE CHECKED WITH NO LEAK.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11646672 ↗
• InjuryDec 30, 2020Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED THAT THE UNIPERC HAD CUFF FAILURE DURING AN AIRWAY EMERGENCY. TRACHEOSTOMY TUBE WAS REMOVED AND THE PATIENT WAS INTUBATED FROM ABOVE. NO ADVERSE EFFECTS.

  Patient problems: Hypoxia

  MAUDE report 11098423 ↗
• InjuryDec 29, 2020Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC HAD CUFF FAILURE DURING AN AIRWAY EMERGENCY. TRACHEOSTOMY TUBE WAS REMOVED AND THE PATIENT WAS INTUBATED FROM ABOVE. NO FURTHER INFORMATION AVAILABLE ON PATIENT OUTCOME.

  Patient problems: Airway Obstruction

  MAUDE report 11090281 ↗
• InjuryDec 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE CUFF ON THE TRACHEOSTOMY TUBE RUPTURED. THE PRODUCT PROBLEM WAS OBSERVED IMMEDIATELY UPON USE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10949971 ↗
• InjuryNov 15, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER THE TRACHEOSTOMY, THE SMITHS MEDICAL CUFF STARTED TO SLOWLY DEFLATE AND A LEAK WAS NOTICED AFTERWARD. CLINICAL CONSEQUENCES WERE DESATURATION AND HYPOXEMIA. A TUBE CHANGE WAS CARRIED OUT. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10841497 ↗
• InjuryJan 15, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT IMMEDIATELY FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX® UNIPERC® ADJUSTABLE TRACHEOSTOMY TUBE, INABILITY TO VENTILATE THE PATIENT WAS OBSERVED. IT WAS REPORTED THAT THE TUBE WAS LEAKING DUE TO THE NON-WATERPROOF BALLOON. SUBSEQUENTLY THE TRACH TUBE WAS CHANGED OUT WITH ANOTHER MODEL. THE PATIENT RECOVERED WITH NO FURTHER ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594312 ↗
• MalfunctionJan 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX UNIPERC ADJUSTABLE FLANGE CUFFED TRACHEOSTOMY TUBE WAS INVOLVED IN A "POSSIBLE PATIENT INCIDENT". NO FURTHER INFORMATION WAS RECEIVED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8209143 ↗
• MalfunctionNov 6, 2018Premature Separation; Premature Separation

  INFORMATION WAS RECEIVED INDICATING THAT THE BLUE LEVER TO A SMITHS MEDICAL PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE CAME OUT WHILE IN USE WITH THE PATIENT. THE TUBE WAS THEN REPORTED TO BE LOOSE, REQUIRING THAT IT BE HELD IN PLACE WHILE THE BLUE LEVER WAS REATTACHED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8043703 ↗
• InjuryMar 21, 2017Loose or Intermittent Connection; Device Operates Differently Than Expected; Device Handling Problem; Loose or Intermittent Connection; Device Operates Differently Than Expected; Device Handling Problem

  IT WAS REPORTED THAT THE PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE WAS USED TO REPLACE THE PATIENT'S EXISTING TRACHEOSTOMY TUBE AS AN ELECTIVE PERCUTANEOUS TRACHEOSTOMY CHANGE IN THE INTENSIVE CARE UNIT. THE TUBE WAS PLACED USING THE GUIDEWIRE AND THE BLUE OBTURATOR INCLUDED WITH THE KIT. THE PLACEMENT OF THE TUBE WAS ASSESSED AS ADEQUATE VIA CHEST X-RAY. ONE DAY AFTER THIS PLACEMENT, THE PATIENT RECEIVED BRONCHOSCOPIC EXAMINATION TO ASSESS THE PATIENT'S CONDITION DUE TO "POOR WEANING FROM THE VENTILATOR OVER THE PREVIOUS FEW DAYS/WEEKS." DURING THE BRONCHOSCOPY, A BLUE PLASTIC FOREIGN BODY WAS IDENTIFIED IN THE RIGHT MAIN BRONCHUS. THE FOREIGN BODY WAS REMOVED UNDER ANESTHESIA ON THE FOLLOWING DAY. ONCE THE FOREIGN BODY WAS REMOVED, IT WAS DETERMINED TO BE THE BLUE "J" TIP STRAIGHTENER FROM THE GUIDEWIRE OF THE UNIPERC ADJUSTABLE FLANGE TRACHEOSTOMY TUBE KIT. IT WAS NOTED THE STRAIGHTENER WAS LOOSE ON THE GUIDEWIRE AND NOT RADIO-OPAQUE BECAUSE IT WAS NOT DETECTED DURING X-RAY. THE REPORTER ACKNOWLEDGED THAT THE INSTRUCTIONS FOR USE DENOTE TO REMOVE THE BLUE "J" TIP STRAIGHTENER PRIOR TO INSERTING THE GUIDEWIRE. THE PATIENT HAD MILD BLOOD-STAINED SECRETIONS AND ASPIRATIO

  Patient problems: Aspiration/Inhalation; Blood Loss; Foreign Body In Patient

  MAUDE report 6421622 ↗