Portex 505070Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10351688000231), received between Jul 10, 2019 and Dec 27, 2022 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT, PRIOR TO USING THE TRACH TUBE-INFLATED CUFF, THE CUFF APPEARED TO BE MISSHAPED SO THE DEVICE WAS NOT USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16052345 ↗
• MalfunctionOct 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BALLOON WAS LEAKING ON THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15596376 ↗
• MalfunctionSep 16, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING DEVICE SETUP, IT FAILED LEAK TEST. BALLOON WOULD NO STAY INFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438778 ↗
• MalfunctionFeb 7, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE CUFF ON THE TUBE APPEARS TO HAVE SLID DOWN THE SHAFT AND PARTIALLY OCCLUDED THE TUBE, CAUSING HIGH PRESSURES, AND INABILITY TO PASS THE SUCTION CATHETER. THE TRACH TUBE WAS REPLACED TO RESOLVE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471770 ↗
• MalfunctionFeb 7, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE CUFF ON THE TUBE APPEARS TO HAVE SLID DOWN THE SHAFT AND PARTIALLY OCCLUDED THE TUBE, CAUSING HIGH PRESSURES, AND INABILITY TO PASS THE SUCTION CATHETER. THE TRACH TUBE WAS REPLACED TO RESOLVE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471271 ↗
• MalfunctionFeb 7, 2022Increase in Pressure; Increase in Pressure

  IT WAS REPORTED THAT THE CUFF ON THE TUBE APPEARS TO HAVE SLID DOWN THE SHAFT AND PARTIALLY OCCLUDED THE TUBE, CAUSING HIGH PRESSURES, AND INABILITY TO PASS THE SUCTION CATHETER. THE TRACH TUBE WAS REPLACED TO RESOLVE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471208 ↗
• InjuryJul 10, 2019Deformation Due to Compressive Stress; Material Deformation; Material Integrity Problem; Deformation Due to Compressive Stress; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT WHEN THE RESPIRATORY THERAPIST (RT) WENT TO PULL OUT THE INNER CANNULA THEY FELT A MODERATE/FULL RESISTANCE. THE RT WAS UNABLE TO PUT THE CANNULA BACK IN AS A RESULT. THE RT CALLED AN ENT PHYSICIAN WHO SCOPED THE PATIENT TRACH TUBE. THE ENT FOUND THE TUBE TO BE KINKED. THE PHYSICIAN REPLACED THE TRACH TUBE AS A RESULT. THE DEFECTIVE TRACH TUBE WAS RETAINED BY THE FACILITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8778805 ↗

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