Portex 101/563/090Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 15019517103427), received between Jan 19, 2024 and Nov 4, 2025 — classified as 9 malfunctions.

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

• MalfunctionNov 4, 2025Crack; Crack

  IT WAS REPORTED THAT AN INCIDENT OCCURRED IN THE INTENSIVE CARE UNIT REGARDING THE PRODUCT, WHERE THE BLUE CONNECTOR ON THE SUBGLOTTIC CANAL WHERE THE SYRINGE IS ATTACHED FOR ASPIRATION IS CRACKED, AND AIR FROM THE ROOM IS ENTERING THE SYRINGE INSTEAD OF MUCUS FROM THE AIRWAY. THERE WAS PATIENT INVOLVEMENT, WHICH LED TO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23470284 ↗
• MalfunctionOct 21, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE SUCTIONAID TRACHEOSTOMY TUBE TAKEN FROM THE SIZE 9 BLUPERC KIT COULD NOT MAINTAIN CUFF PRESSURE. CUFF PRESSURE MANOMETER OBSERVATIONS CONFIRMED LOSS OF PRESSURE WHILE IN-USE WITH THE PATIENT. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23352708 ↗
• MalfunctionAug 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE ABOVE-CUFF SUCTION AID BLUE PORT WAS CRACKED, AND THE TRACHEOSTOMY WAS SUCCESSFULLY CHANGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883951 ↗
• MalfunctionJun 14, 2025Decrease in Suction; Decrease in Suction

  IT WAS REPORTED THAT THE HEALTHCARE PROVIDER WAS UNABLE TO PASS WHITE SLIM DILATOR THROUGH PURPLE INTRODUCER DUE TO NARROWING OF DILATOR. THE EVENT DID PROLONG THE TRACHEOSTOMY. THERE WAS REPORTED PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22208137 ↗
• 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 19661772 ↗
• 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 19222029 ↗
• MalfunctionMay 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 19220826 ↗
• MalfunctionMay 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 19220807 ↗
• MalfunctionJan 19, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT WHEN THE PURCHASED PRODUCT ARRIVED, THE OPERATOR CHECKED IT AND FOUND A SAMPLE STICKER ON THE BOX. NO PATIENT INVOLVEMENT REPORTED. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545686 ↗