Portex 503080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688006677), received between Oct 1, 2020 and Oct 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES DIC KEPT ON POPPING OUT WHEN INSERTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10613327 ↗

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