Portex 513060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688001481), received between Mar 23, 2020 and Mar 23, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2020Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITH MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES DIC REQUIRED CHANGE OUT BEFORE THE FOUR WEEKS OF USE AND SCHEDULED CHANGE OUT. THE REASON REPORTED WAS THE TRACHEOSTOMY HAS A LEAK. THE REPORTED INDICATED THAT THIS OCCURRED A TOTAL OF THREE EVENTS REQUIRING CHANGE OUT WITH A CERTAIN 3865716 LOT . NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9869271 ↗
• MalfunctionMar 23, 2020Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITH MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES DIC REQUIRED CHANGE OUT BEFORE THE FOUR WEEKS OF USE AND SCHEDULED CHANGE OUT. THE REASON REPORTED WAS THE TRACHEOSTOMY HAS A LEAK. THE REPORTED INDICATED THAT THIS OCCURRED A TOTAL OF THREE EVENTS REQUIRING CHANGE OUT WITH A CERTAIN 3865716 LOT . NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9869270 ↗
• MalfunctionMar 23, 2020Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITH MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES DIC REQUIRED CHANGE OUT BEFORE THE FOUR WEEKS OF USE AND SCHEDULED CHANGE OUT. THE REASON REPORTED WAS THE TRACHEOSTOMY HAS A LEAK. THE REPORTED INDICATED THAT THIS OCCURRED A TOTAL OF THREE EVENTS REQUIRING CHANGE OUT WITH A CERTAIN 3865716 LOT . NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9869268 ↗

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