Portex 101/858/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 15019517077865), received between May 7, 2021 and Feb 21, 2025 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Disconnection” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE INNER CANNULA DID NOT FIT SECURELY, IT IS EASY TO REMOVE. THIS IS CAUSING PROBLEM IN THE HOSPITAL THAT COULD LEAD TO AN EVENT, APPRECIATE YOUR IMMEDIATE RESPONSE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437353 ↗
• MalfunctionNov 11, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT THE INNER TRACH CANNULA DID NOT POSITIVELY CLICK INTO PLACE WHEN PERFORMING A TRACH CHANGE ON A PATIENT IN THE INTENSIVE CARE UNIT (ICU). THE RIB AROUND THE INNER CANNULA WASN'T CLICKING INTO THE OUTER CANNULA, IT WAS SLIDING IN AND OUT WITHOUT INTERFERENCE, LEADING TO POSSIBLE ¿POPPING OUT¿ OF THE INNER CANNULA. THE HEALTH PROFESSIONAL TRIED A SECOND ONE TO FIND THE SAME ISSUE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652108 ↗
• MalfunctionNov 11, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT THE INNER TRACH CANNULA DID NOT POSITIVELY CLICK INTO PLACE WHEN PERFORMING A TRACH CHANGE ON A PATIENT IN THE INTENSIVE CARE UNIT (ICU). THE RIB AROUND THE INNER CANNULA WASN'T CLICKING INTO THE OUTER CANNULA, IT WAS SLIDING IN AND OUT WITHOUT INTERFERENCE, LEADING TO POSSIBLE ¿POPPING OUT¿ OF THE INNER CANNULA. THE HEALTH PROFESSIONAL TRIED A SECOND ONE TO FIND THE SAME ISSUE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652097 ↗
• MalfunctionOct 1, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE INNER CANNULA DID NOT CLICK. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344576 ↗
• MalfunctionOct 1, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE INNER CANNULA DID NOT CLICK. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344538 ↗
• MalfunctionOct 1, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE INNER CANNULA DID NOT CLICK. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344289 ↗
• MalfunctionOct 1, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE INNER CANNULA DID NOT CLICK. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343987 ↗
• MalfunctionSep 20, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THEY HAD FIT ISSUES WITH THE DEVICE. THIS ISSUE WAS RELATED TO THEIR PREVIOUS REPORTS WHERE THE INNER CANNULA WAS NOT CLICKING IN PLACE IN THE TRACH AND CAN SLIDE RIGHT OUT. ADDITIONALLY, IT WAS STATED THAT THE DEFECT WAS SEEN AT UMROI FACILITIES WHEN AN RT HIGHLIGHTED THE ISSUE AFTER HE AND A NURSE PRACTITIONER ENCOUNTERED FIT PROBLEMS WITH SEVERAL PATIENTS. A DIFFERENT LOT NUMBER WAS FOUND THAT WORKED FOR THE PATIENT, AND THE STAFF WAS INFORMED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272723 ↗
• MalfunctionSep 20, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE INNER CANNULA WAS NOT CLICKING INTO PLACE INSIDE THE TRACH AND CAN SLIDE RIGHT OUT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20272284 ↗
• MalfunctionSep 20, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THEY HAD FIT ISSUES WITH THE DEVICE. THIS ISSUE WAS RELATED TO THEIR PREVIOUS REPORTS WHERE THE INNER CANNULA WAS NOT CLICKING IN PLACE IN THE TRACH AND CAN SLIDE RIGHT OUT. ADDITIONALLY, IT WAS STATED THAT THE DEFECT WAS SEEN AT UMROI FACILITIES WHEN AN RT HIGHLIGHTED THE ISSUE AFTER HE AND A NURSE PRACTITIONER ENCOUNTERED FIT PROBLEMS WITH SEVERAL PATIENTS. A DIFFERENT LOT NUMBER WAS FOUND THAT WORKED FOR THE PATIENT, AND THE STAFF WAS INFORMED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271750 ↗
• MalfunctionSep 20, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THEY HAD FIT ISSUES WITH THE DEVICE. THIS ISSUE WAS RELATED TO THEIR PREVIOUS REPORTS WHERE THE INNER CANNULA WAS NOT CLICKING IN PLACE IN THE TRACH AND CAN SLIDE RIGHT OUT. ADDITIONALLY, IT WAS STATED THAT THE DEFECT WAS SEEN AT UMROI FACILITIES WHEN AN RT HIGHLIGHTED THE ISSUE AFTER HE AND A NURSE PRACTITIONER ENCOUNTERED FIT PROBLEMS WITH SEVERAL PATIENTS. A DIFFERENT LOT NUMBER WAS FOUND THAT WORKED FOR THE PATIENT, AND THE STAFF WAS INFORMED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271625 ↗
• MalfunctionSep 20, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THEY HAD FIT ISSUES WITH THE DEVICE. THIS ISSUE WAS RELATED TO THEIR PREVIOUS REPORTS WHERE THE INNER CANNULA WAS NOT CLICKING IN PLACE IN THE TRACH AND CAN SLIDE RIGHT OUT. ADDITIONALLY, IT WAS STATED THAT THE DEFECT WAS SEEN AT UPPER CHESAPEAKE WHEN AN RT HIGHLIGHTED THE ISSUE AFTER HE AND A NURSE PRACTITIONER ENCOUNTERED FIT PROBLEMS WITH SEVERAL PATIENTS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271585 ↗
• MalfunctionSep 18, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE INNER CANNULA WAS NOT CLICKING INTO PLACE INSIDE THE TRACH AND CAN SLIDE RIGHT OUT. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251879 ↗
• MalfunctionSep 18, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SIZE 8 INNER CANNULA WAS NOT LOCKING INTO PLACE IN THE TRACH AND CAN SLIDE RIGHT OUT. TRIED THE NEW LOT# RECEIVED AND IT'S ALSO NOT CLICKING IN PLACE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245852 ↗
• MalfunctionSep 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULAS WERE FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACHS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239713 ↗
• MalfunctionSep 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULAS WERE FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACHS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239617 ↗
• MalfunctionSep 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULAS WERE FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACHS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239607 ↗
• MalfunctionSep 17, 2024Disconnection; Disconnection

  ADDITIONAL INFORMATION WAS RECEIVED STATING, THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239548 ↗
• MalfunctionSep 17, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULAS WERE FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACHS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239493 ↗
• MalfunctionSep 17, 2024Connection Problem; Connection Problem

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239072 ↗
• MalfunctionSep 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULAS WERE REPORTEDLY FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACH. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237865 ↗
• MalfunctionSep 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULAS WERE REPORTEDLY FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACH. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237806 ↗
• MalfunctionSep 17, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULA WAS REPORTEDLY FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACH. MM QUALITY CHECKED NEW SIZE 8.0 TRACHS WITH A NEW INNER CANNULA. IT DID NOT FEEL THE INNER CANNULA CLICK INTO THE TRACH. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237733 ↗
• MalfunctionSep 12, 2024Disconnection; Fitting Problem; Disconnection; Fitting Problem

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULAS WERE REPORTEDLY FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACH. THE EVENT OCCURRED DURING QUALITY CONTROL TESTING AT SUPPLY ROOM ON UNUSED EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200815 ↗
• MalfunctionSep 12, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE SIZE 8.0 INNER CANNULAS WERE REPORTEDLY FALLING OUT AND NOT CLICKING INTO SIZE 8.0 TRACH. THE EVENT OCCURRED DURING QUALITY CONTROL TESTING AT SUPPLY ROOM ON UNUSED EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20200758 ↗