Portex 513070Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688023544), received between Sep 8, 2022 and Sep 8, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation 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.

• MalfunctionSep 8, 2022Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT THE TRACH DOES NOT INFLATE, WHEN PUT IN WATER, YOU CAN SEE THERE IS A HOLE IN IT. NOT USED ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15383272 ↗

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