Portex 101/563/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517103403), received between Sep 14, 2023 and Sep 17, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Crack” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Unintended Deflation

  It was reported that the trach tube was faulty and balloon constantly deflated during use with patient. Tube in-situ. Medical intervention was required. There was unknown patient harm or adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809421 ↗
• MalfunctionOct 9, 2024Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408408 ↗
• 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 19222000 ↗
• 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 19220850 ↗
• InjurySep 14, 2023Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE DEVICE DID NOT WORK AS INTENDED, DUE TO THE TRACHEOSTOMY CUFF "NOT HOLDING UP". PATIENT WAS INVOLVED, NO PATIENT INJURY OR ADVERSE EFFECTS REPORTED. PATIENT INFORMATION IS NOT AVAILABLE. THE PATIENT WAS FASTED FOR POTENTIAL TRACHEOSTOMY CHANGE BY TRACHEOSTOMY TEAM AFTER REVIEWING IN THE MORNING. DURING THE TRACHEOSTOMY TEAM ROUNDS THE CUFF PRESSURE WAS CHECKED AND RE-INFLATED. THEN RECHECKED AFTER AN HOUR AND CONFIRMED THAT IT HAD DROPPED DOWN TO 18CM OF H20 FROM 24CM OF H20 WITHIN AN HOUR. TRACHEOSTOMY TUBE WAS CHANGED BY TRACHEOSTOMY TEAM CONSULTANT. THE TRACHEOSTOMY TUBE THAT HAD BEEN REMOVED WAS CHECKED BY THE TRACHEOSTOMY TEAM AND WHEN SUBMERGED IN WATER THERE WAS WATER BUBBLES INSIDE THE CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17749230 ↗