Portex 503070Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10351688009265), received between Nov 17, 2017 and May 14, 2024 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 reports).

2 other recalls cover devices cleared under the same FDA submission (K934465); they may or may not involve this specific model.

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.

• MalfunctionMay 14, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS THE PRESENCE OF WATER (CONDENSATION) IN THE CUFF, AS WELL AS THE BALLOON TUBING, DURING THE LAST CANNULA CHANGE. TRACH INSTALLED ON (B)(6) 2023, AND CHANGED ON (B)(6) 2024 (DOCUMENTED ON (B)(4)). THE TRACH INSTALLED ON (B)(6) WAS CHANGED ON (B)(6) AND THE HOSPITAL NOTED THE SAME THING: MOISTURE IN THE MAIN BALLOON (0.5 CC REMOVED). THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315667 ↗
• MalfunctionJun 1, 2023Inflation Problem; Material Integrity Problem

  WHILE INFLATING CUFF ON THE PATIENTS TRACH, UNABLE TO INFLATE THE CUFF AND FOUND THE CUFF TO BE BLOWN ON TWO SEPARATE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038139 ↗
• MalfunctionSep 19, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY IS NOT HOLDING FLUID. IT WAS NOTED THAT THE BULBS ARE DEFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7889139 ↗
• MalfunctionSep 18, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY IS NOT HOLDING FLUID. IT WAS NOTED THAT THE BULBS ARE DEFECTIVE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7884751 ↗
• MalfunctionSep 13, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® CUFFED FLEX D.I.C® TRACHEOSTOMY TUBE WAS NOT HOLDING FLUID. IT WAS REPORTED THAT THE FLUID LEAKS OUT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874567 ↗
• MalfunctionSep 13, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® CUFFED FLEX D.I.C® TRACHEOSTOMY TUBE WAS NOT HOLDING FLUID. IT WAS REPORTED THAT THE FLUID LEAKS OUT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874519 ↗
• MalfunctionSep 13, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® CUFFED FLEX D.I.C® TRACHEOSTOMY TUBE WAS NOT HOLDING FLUID. IT WAS REPORTED THAT THE FLUID LEAKS OUT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874485 ↗
• MalfunctionSep 13, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® CUFFED FLEX D.I.C® TRACHEOSTOMY TUBE WAS NOT HOLDING FLUID. IT WAS REPORTED THAT THE FLUID LEAKS OUT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7874450 ↗
• InjuryNov 17, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SMITHS MEDICAL DEVICE LEAKED AFTER WEEKS OF USE. DUE TO THE INCIDENT, AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WAS REQUIRED AND THE PATIENT WAS PLACED ON A VENTILATOR. NO INJURY WAS REPORTED. THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7041164 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934465. One submission often covers many models, so check the product and lot details in each record.

• Z-0229-05 · Sep 9, 2004 · Terminated
  Portex Lo-Profile Tracheostomy Tube Decannulation Cap Catalog Number: 582000
• Z-0228-05 · Sep 9, 2004 · Terminated
  Portex Tracheostomy Tube Decannulation Cap for use only with Fenestrated Tracheostomy Tubes Catalog Number: 519000