Portex 100/870/075CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315104855), received between Apr 7, 2022 and Mar 7, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2025Inflation Problem; Inflation Problem

  IT WAS STATED THAT THE BALLOON DID NOT INFLATE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548673 ↗
• InjuryOct 18, 2022Suction Problem; Suction Problem

  IT WAS REPORTED THAT ON ROUTINE ROUNDING, TRACHEOSTOMY PHYSIOTHERAPY TEAM REPORTED THAT THE SUCTION AID PORT WAS NOT WORKING. IT WAS NOTED THAT THERE WAS A CRACK IN THE SUCTION PORT. TRACHEOSTOMY TUBE HAD BEEN INSERTED APPROXIMATELY 14 DAYS PRIOR. DUTY INTENSIVIST NOTIFIED AND PATIENT WAS FASTED FOR AN URGENT TRACHEOSTOMY TUBE CHANGE AND TRACH TUBE WAS CHANGED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625391 ↗
• MalfunctionJun 27, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKED DURING TESTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14837917 ↗
• InjuryMay 21, 2022Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THE TRACH TUBE HAD A SUBGLOTTIC PORT SPLIT; SPECIFICALLY ON THE BLUE END WHERE THE SYRINGE ATTACHES. THIS TRACH TUBE WAS INSERTED ON (B)(6) 2022. THE CUSTOMER WAS UNABLE TO ASPIRATE ANY SUBGLOTTIC SECRETIONS. A PREMATURE TRACH TUBE CHANGE (LIKE FOR LIKE') WAS SUCCESSFULLY COMPLETED. THE CUSTOMER WAS THEN ABLE TO SUCCESSFULLY ASPIRATE 3ML OF SECRETIONS FROM THE REPLACEMENT DEVICE'S PORT. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Airway Obstruction; Decreased Respiratory Rate

  MAUDE report 14465975 ↗
• MalfunctionApr 7, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT BEFORE INSERTION, DURING PRE-TEST: CUFF WOULD NOT INFLATE. NO CLINICAL CONSEQUENCE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14040824 ↗