Portex 505080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688021007), received between Jul 24, 2019 and Mar 18, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2021Gas/Air Leak; Gas/Air Leak

  DEVICE EVALUATION COMPLETED AND SUMMARY.

  Patient problems: Airway Obstruction

  MAUDE report 11519084 ↗
• MalfunctionJul 24, 2019Contamination; Residue After Decontamination; Contamination; Residue After Decontamination

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX CUFFED FLEX D.I.C TRACHEOSTOMY TUBE PILOT BALLOON WAS BLACK ON THE INSIDE AND SLIGHTLY WENT UP THE TUBE. THE ISSUE WAS DISCOVERED UPON CLEANING. IT WAS ALSO REPORTED THE PATIENT WAS STILL USING THE DEVICE UNTIL A ROUTINE TRACHEOSTOMY CHANGE OUT WAS PERFORMED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8822325 ↗

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