Portex 101/870/085CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15019517076233), received between Oct 1, 2020 and Jul 2, 2026 — classified as 1 death, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Material Rupture

  IT WAS REPORTED THAT A RUPTURE OF THE CUFF WAS OBSERVED FOLLOWING INSERTION OF THE TRACH TUBE. THE OUTCOME OF THE EVENT WAS RESOLVED BY REPLACEMENT. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25694496 ↗
• MalfunctionMar 6, 2026Material Rupture

  IT WAS REPORTED THAT A RUPTURE OF THE CUFF WAS OBSERVED FOLLOWING INSERTION OF THE TRACH TUBE. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528120 ↗
• MalfunctionFeb 3, 2026Material Rupture

  IT WAS REPORTED THAT A RUPTURE OF THE CUFF WAS OBSERVED FOLLOWING INSERTION OF THE TRACH TUBE. THE OUTCOME OF THE EVENT WAS RESOLVED BY REPLACEMENT. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24252364 ↗
• MalfunctionJul 21, 2025Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON CAME LOOSE AFTER 10 DAYS OF USE. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22555346 ↗
• MalfunctionJul 21, 2025Fitting Problem; Adverse Event Without Identified Device or Use Problem; Fitting Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED DUE TO PROBLEMS WITH THE DEVICE. THE BALLOON WAS DEFLATING, AND THE PATIENT WAS MICROASPIRATING, WHICH CONTRIBUTED TO THE DEATH. ACCORDING TO THE CAREGIVER, THE PATIENT ASPIRATED MULTIPLE TIMES, ULTIMATELY RESULTING IN DEATH BY BRONCHOASPIRATION CAUSED BY A CANNULA OBSTRUCTING THE AIRWAY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554974 ↗
• DeathJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED DUE TO PROBLEMS WITH THE DEVICE. THE BALLOON WAS DEFLATING, AND THE PATIENT WAS MICROASPIRATING, WHICH CONTRIBUTED TO THE DEATH. ACCORDING TO THE CAREGIVER, THE PATIENT ASPIRATED MULTIPLE TIMES, ULTIMATELY RESULTING IN DEATH BY BRONCHOASPIRATION CAUSED BY A CANNULA OBSTRUCTING THE AIRWAY.

  Patient problems: Insufficient Information

  MAUDE report 22554133 ↗
• MalfunctionJul 18, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A PROBLEM, THE BALLOON DID NOT REMAIN INFLATED; IT STARTED DEFLATING IMMEDIATELY AFTER INFLATION. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22546923 ↗
• MalfunctionDec 6, 2024Deflation Problem; Ventilation Problem in Device Environment; Deflation Problem; Ventilation Problem in Device Environment

  IT WAS STATED THAT THE BLUE BALLOON DEFLATED, AND THE CAP CAME OFF WHILE THE DEVICE WAS USED ON PATIENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT. PATIENT WAS A MALE WHO WEIGHTS 62 KG. HE WAS NOT PRESCRIBED ANY MEDICAL TREATMENT. THE PATIENT WAS REPORTED TO TAKE MEDICATIONS CONCOMITANTLY VIA GPE (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY). THE EVENT WAS RESOLVED AFTER CHANGING THE CANNULA. THERE WAS PATIENT INVOLVEMENT, BUT NO CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20868105 ↗
• MalfunctionJun 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF LEAKED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601776 ↗
• MalfunctionDec 2, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE WET NOSE DOES NOT STOP PROPERLY ON THE TK CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919394 ↗
• MalfunctionOct 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT DURING PRECHECK HAD NO ANOMALY IN THE PRODUCT WAS OBSERVED. THE CUSTOMER STARTED TO USE IT. AND AFTER A COUPLE OF DAYS, WHEN HE CHECKED THE CUFF'S AIR PRESSURE, HE NOTICED THE PILOT BALLOON WAS DETACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10613524 ↗