Portex 101/810/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15019517076301), received between Sep 16, 2022 and Mar 18, 2026 — classified as 1 injury, 9 malfunctions.

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

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Gas/Air Leak

  IT WAS STATED THAT THE PATIENT TO REPLACE THE NO. 8 TRACHEAL TUBE. NO ABNORMALITIES WERE OBSERVED AFTER THE REPLACEMENT. IT WAS REPORTED THAT BUBBLES APPEARED AT THE CORNER OF THE PATIENT'S MOUTH AFTER USING THE VENTILATOR. THERE WAS PATIENT INVOLVEMENT/NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634279 ↗
• MalfunctionAug 5, 2025Crack; Crack

  IT WAS REPORTED THAT THE CANNULA WAS CRACKED. THE REPORTER NOTED THAT THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT AND THE PROCEDURE WAS TREATMENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720618 ↗
• InjuryJun 19, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT WAS LEAKING CONTINUOUSLY, RIGHT AFTER INSERTION, BECAUSE THE BALLOON WAS PUNCTURED. THE PRODUCT WAS WITHDRAWN FROM THE PATIENT AND REPLACED WITH ANOTHER CANNULA. THE EVENT HAPPENED AT THE PATIENT'S HOME. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289520 ↗
• MalfunctionAug 13, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRODUCT COULD NOT BE USED BECAUSE THE BALLOON WAS DEFECTIVE AND DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973567 ↗
• MalfunctionDec 20, 2023Device Damaged Prior to Receipt by User; Material Deformation; Device Damaged Prior to Receipt by User; Material Deformation

  IT WAS REPORTED THAT THE DEVICE HAD BEEN "SQUEEZED" DURING TRANSPORTATION AND WAS NOT SENT TO THE HOSPITAL FOR CLINICAL USE AND WAS UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18367590 ↗
• MalfunctionDec 14, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT HAD TWO (2) CANNULAS DELIVERED, AND BOTH WERE FOUND TO BE FAULTY (BROKEN) AT OPENING AND UNABLE TO BE USED. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED AND THE OUTCOME WAS REPORTED AS RESOLVED. (B)(4) AND (B)(4) REPRESENT THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326513 ↗
• MalfunctionDec 14, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT A PATIENT HAD TWO (2) CANNULAS DELIVERED, AND BOTH WERE FOUND TO BE FAULTY (BROKEN) AT OPENING AND UNABLE TO BE USED. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED AND THE OUTCOME WAS REPORTED AS RESOLVED. (B)(6) AND (B)(6) REPRESENT THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326511 ↗
• MalfunctionAug 30, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUFF TORE DURING USE (ONE WEEK AFTER INTUBATION). NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649638 ↗
• MalfunctionAug 1, 2023Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT A CRACK OCCURRED WHILE CLEANING THE INNER TUBE. THE CUSTOMER REPORTED THAT THIS WAS THE FIRST TIME THAT SUCH AN EVENT HAS HAPPENED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17433341 ↗
• MalfunctionSep 16, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CANNULA DID NOT FIT NICELY ROUND THE SIZE 8 INTRODUCER IN THIS KIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15438385 ↗