Portex 101/563/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 15019517103410), received between Feb 17, 2022 and Apr 24, 2026 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 24, 2026Gas/Air Leak

  IT WAS REPORTED THERE HAVE BEEN SEVERAL ISSUES WITH LEAKING PERC TRACHEOSTOMIES RECENTLY. SINCE THE CHANGE IN THE DESIGN OF THE DILATOR, TRACHEOSTOMIES HAVE DEVELOPED SIGNIFICANT LEAKS IN THE DAYS AFTER INSERTION. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24985179 ↗
• InjuryApr 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT SINCE THE CHANGE IN THE DESIGN OF THE DILATOR, TRACHEOSTOMIES HAVE DEVELOPED SIGNIFICANT LEAKS IN THE DAYS AFTER INSERTION, NECESSITATING A RETURN TO THEATRE FOR SURGICAL TRACHEOSTOMY INSERTION. IT WAS ALSO STATED THAT THE END OF THE TRACHEOSTOMY WAS ABUTTING THE ANTERIOR WALL. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925817 ↗
• InjuryApr 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT SINCE THE CHANGE IN THE DESIGN OF THE DILATOR, TRACHEOSTOMIES HAVE DEVELOPED SIGNIFICANT LEAKS IN THE DAYS AFTER INSERTION, NECESSITATING A RETURN TO THEATRE FOR SURGICAL TRACHEOSTOMY INSERTION. IN ONE SPECIFIC CASE THERE WAS A CONCERN THAT THE TRACHEOSTOMY HAD INJURED THE ANTERIOR TRACHEAL WALL AT INSERTION AND HAD CREATED A FALSE PASSAGE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925802 ↗
• MalfunctionFeb 12, 2026Crack

  IT WAS REPORTED THAT THERE WAS A CRACK IN SUBGLOTTIC SUCTION PORT WHILE TREATED FOR RESPIRATORY FAILURE. AS A CLINICAL OUTCOME, THE ALLEGED DAMAGE WAS THE INABILITY TO ASPIRATE SUBGLOTTIC SUCTION PORT. IT REMAINS NEAR MISS AT PRESENT. THE INCIDENT OCCURRED DURING THE MECHANICAL VENTILATION VIA TRACHEOSTOMY TUBE. THERE WAS PATIENT INVOLVEMENT BUT, NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321856 ↗
• MalfunctionNov 20, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE TRACHEOSTOMY PROCEDURE IT WAS OBSERVED BY THE DOCTOR THAT THE CUFF WAS NOT INFLATING ADEQUATELY. THE DEVICE WAS NOT IN USE AFTER INCIDENCE. THE EVENT OCCURRED AT HOSPITAL DURING USE. THE OPERATOR OF THE DEVICE WAS HEALTHCARE PROFESSIONAL. THERE WAS 1 QUANTITY AFFECTED. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606967 ↗
• MalfunctionNov 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF THE INITIAL WHITE DILATOR SPLIT DESPITE EASY INSERTION, FIRST PASS. THE PROCEDURE COMPLETED UNEVENTFULLY DESPITE THE SPLIT IN THE TIP OF THE DILATOR. THERE WAS NO INJURY OR DAMAGE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727062 ↗
• InjuryNov 19, 2024Crack; Crack

  IT WAS REPORTED THAT THE SUBGLOTTIC PORT WAS CRACKED AND UNUSABLE. THE TUBE WAS REMOVED AND REPLACED. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS NO INJURY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724508 ↗
• MalfunctionNov 19, 2024Crack; Crack

  IT WAS REPORTED THAT THE SUBGLOTTIC PORT WAS CRACKED AND UNUSABLE. IT REMAINS IN SITU AS THE PATIENT IS TOO UNWELL TO REPLACE THE TUBE AT THIS TIME. UNABLE TO PROVIDE SUCTION AROUND THE CUFF TO PATIENT DUE TO THE FAULTS. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THE ISSUE WAS NOT RESOLVED. THERE WAS NO INJURY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724389 ↗
• MalfunctionNov 12, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF IS LEAKING. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20666809 ↗
• MalfunctionOct 29, 2024Missing Information; Missing Information

  IT WAS REPORTED THAT THE WRITING ON PILOT BALLOON RUBBED OFF, UNABLE TO SEE SIZE OR CUFF PRESSURE. THE EVENT DISCOVERED WHILE THE TRACHEOSTOMY TUBE WAS STILL IN-SITU (PATIENT WAS TRANSFERRED TO THE WARD FROM ICU AND ISSUE WAS NOTED WHEN ADMITTED TO THE TRACHE TEAM). THERE WAS PATIENT INVOLVEMENT BUT NO INJURY/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559277 ↗
• MalfunctionOct 9, 2024Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A DIFFICULTY INSERTING GAUGE STAGE DILATOR, INCREASED FLEXIBILITY AND UPON REMOVAL OF THE GAUGE STAGE DILATOR NOTICED DAMAGE TO THE TIP. THE SINGLE STAGE DILATOR FELT MORE FLEXIBLE THAN USUAL, ALSO IMPEDING THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408252 ↗
• InjuryAug 14, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO OR HAVING DIFFICULTY IN ASPIRATING FROM THE SUBGLOTTIC PORT DUE TO BROKEN PLASTIC. THE PATIENT WAS UNDERGOING LONG TERM VENTILATORY WEAN. THE PATIENT WAS SEDATED AND UNABLE TO BE WEANED OFF THE VENTILATOR DUE TO A MULTITUDE OF FACTORS. PERCUTANEOUS TRACHEOSTOMY INSERTION WAS PERFORMED AS A RESULT. THE TRACHEOSTOMY WAS CHANGED OR REMOVED WHEN CLINICALLY APPROPRIATE. THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. THERE WERE NO REPORTS OF ANY HARM CAUSED, BUT IT WAS DIFFICULT TO MANAGE PATIENT'S RESPIRATORY WEAN DUE TO SECRETION LOAD ABOVE THE CUFF. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 19984774 ↗
• InjuryAug 14, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO OR HAVING DIFFICULTY IN ASPIRATING FROM THE SUBGLOTTIC PORT DUE TO BROKEN PLASTIC. THE PATIENT WAS UNDERGOING LONG TERM VENTILATORY WEAN. THE PATIENT WAS SEDATED AND UNABLE TO BE WEANED OFF THE VENTILATOR DUE TO A MULTITUDE OF FACTORS. PERCUTANEOUS TRACHEOSTOMY INSERTION WAS PERFORMED AS A RESULT. THE TRACHEOSTOMY WAS CHANGED OR REMOVED WHEN CLINICALLY APPROPRIATE. THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. THERE WERE NO REPORTS OF ANY HARM CAUSED, BUT IT WAS DIFFICULT TO MANAGE PATIENT'S RESPIRATORY WEAN DUE TO SECRETION LOAD ABOVE THE CUFF. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 19983615 ↗
• MalfunctionJul 19, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE WRITING RUBBED OFF ON THE PILOT BALLOON. THE TUBE WAS INSERTED (B)(6) 2023. THE WRITING WAS NO LONGER VISIBLE AFTER DEVICE HAD BEEN IN FOR 3 WEEKS. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19783899 ↗
• InjuryJul 5, 2024Crack; Crack

  IT WAS REPORTED THAT DURING ASPIRATION THE SUBGLOTTIC PORT CRACKED DURING ASPIRATION. MEDICAL INTERVENTION WAS REQUIRED, MEANING THAT THE TRACHEOSTOMY TUBE HAD TO BE CHANGED. THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19684388 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT WITH THE DEVICE THE PATIENT WAS UNABLE TO OR HAVING DIFFICULTIES IN ASPIRATING FROM SUBGLOTTIC PORT DUE TO BROKEN PLASTIC, MAKING WEANING OF PATIENT CHALLENGING DUE TO A POTENTIAL ASPIRATION RISK. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661638 ↗
• MalfunctionMay 1, 2024Crack; Crack

  IT WAS REPORTED THAT THE SUCTION AID PORT CRACKED, MAKING IT DIFFICULT TO ASPIRATE SECRETIONS ON THE PATIENT. THIS POTENTIALLY CAUSED AN INCREASED RISK IN ASPIRATION PNEUMONIA. "AS THIS IS SOMEONE¿S AIRWAY THE DEVICE CAN NOT BE CHANGED EASILY. THESE ARE FOR THE TUBES THAT HAD BEEN PERCUTANEOUSLY INSERTED ON DIFFERENT SIZE TUBES." THE DEVICE WAS ALREADY INSERTED IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM/ADVERSE EVENT REPORTED. THE EVENT OCCURRED IN THE HOSPITAL DURING. "STEPS TO RESOLVE THE ISSUE: NEED TO MARK TUBES AND HIGHLIGHT THE PROBLEM. HAD THE WHOLE TUBE CHANGED WHEN PATIENT WAS ABLE TO. ISSUE RESOLVED: NO."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19221990 ↗
• InjuryMay 1, 2024Crack; Incomplete or Inadequate Connection; Crack; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE SUCTIONAID PORT CRACKED, MAKING IT DIFFICULT TO ASPIRATE SECRETIONS ON PATIENTS WITH THE POTENTIAL TO CAUSE INCREASED RISK IN ASPIRATION PNEUMONIA. OCCURRING IN MULTIPLE TUBES NOW ON THE BLU SELECT PORTEX SUCTIONAID TUBE. THE EVENT OCCURRED IN THE HOSPITAL WHILE IN USE WITH PATIENT AND THE DEVICE WAS OPERATED BY A HEALTHCARE PROFESSIONAL. THE ISSUE WAS NOT REVOLVED. THERE WAS A NEED TO MARK THE TUBES AND HIGHLIGHT THE PROBLEM AND HAVE THE WHOLE TUBE CHANGED WHEN THE PATIENT WAS ABLE TO. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220830 ↗
• InjuryMar 20, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED, BY THE SPEECH PATHOLOGIST. THAT THE WRITING ON THE PILOT BALLOON WAS RUBBED OFF, WHILE THE PATIENT WAS IN THE ICU. THE EVENT OCCURRED, IN THE ICU DEPARTMENT OF THE HOSPITAL. THE TRACH WAS CHANGED. NO CHEMICALS WERE USED TO CLEAN THE PILOT BALLOON. NO HARM REPORTED. THE PILOT BALLOON IS USED, AS A CLINICIAN RESOURCE TO ENSURE CUFF IS INFLATED TO CORRECT PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18944659 ↗
• MalfunctionFeb 5, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AT THE FIRST MEETING OF THE PATIENT AND THE TRACHEOSTOMY TEAM ADMISSION ON THE (B)(6) 2023 IT WAS NOTED THAT PILOT BALLOON WRITING WAS NOT VISIBLE. TRACHEOSTOMY TUBE WAS INSERTED ON THE (B)(6) 2023. IT WAS ONLY IN-SITU FOR 15 DAYS. TRACHEOSTOMY TUBE WAS SAVED FOR REPORTING ON THE(B)(6) 2023 AS PATIENT HAD TRACHEOSTOMY CHANGE. THE EVENT OCCURRED IN THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18643353 ↗
• MalfunctionFeb 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE PRODUCT WAS INDWELLED, THE INFLATION LINE GOT DETACHED. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552687 ↗