Portex 100/870/080CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 15019315104862), received between May 15, 2018 and Sep 23, 2026 — classified as 1 death, 6 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (8 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876427 ↗
• DeathMay 12, 2026Insufficient Device Problem Information

  IT WAS STATED THAT THERE COULD HAVE BEEN AN ISSUE WITH THIS ITEM AS THE PATIENT¿S CONDITION GOT WORSE AND THEN PASSED AWAY. THERE WAS PATIENT INVOLVEMENT AND THE PATIENT DIED. CLINICAL EVALUATION WAS DONE. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED, AND THERE WAS INSUFFICIENT OBJECTIVE INFORMATION (PHOTOS/LOGS/HISTORY) TO DETERMINE PROBABLE CAUSE OR FAILURE MODE. MEDICAL CAUSALITY / RELATEDNESS ASSESSMENT PATIENT OUTCOME SEVERITY: DEATH. CAUSAL RELATIONSHIP TO DEVICE PERFORMANCE: INDETERMINATE BASED ON CURRENTLY AVAILABLE INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 25150499 ↗
• MalfunctionMar 11, 2026Material Split, Cut or Torn

  IT WAS STATED THAT DURING THE SURGICAL TRACHEOSTOMY PROCEDURE, THE CUFF BALLOON RUPTURED IN TWO CANNULAS SUCCESSIVELY, WITHOUT ANY PERCEPTIBLE CAUSE. THE EVENT WAS DETECTED DURING CLINICAL USE, AND THE CUSTOMER CLASSIFIED THE INCIDENT AS A RUPTURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24572039 ↗
• MalfunctionJan 8, 2026Material Split, Cut or Torn

  IT WAS STATED THAT DURING THE SURGICAL TRACHEOSTOMY PROCEDURE, THE CUFF BALLOON RUPTURED IN TWO CANNULAS SUCCESSIVELY, WITHOUT ANY PERCEPTIBLE CAUSE. THE EVENT WAS DETECTED DURING CLINICAL USE, AND THE CUSTOMER CLASSIFIED THE INCIDENT AS A RUPTURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24014928 ↗
• MalfunctionJul 21, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CANNULA WAS REPLACED AND AFTER A FEW MINUTES IT WAS OBSERVED THAT THE CUFF INFLATION WAS DEFICIENT, SINCE IT DEFLATED SPONTANEOUSLY; AFTER TESTING THE CUFF, IT WAS FOUND TO BE PUNCTURED. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22558865 ↗
• MalfunctionJun 24, 2025Crack; Crack

  IT WAS REPORTED THAT INCIDENT OF PORTEX TRACHEOSTOMY TUBE SIZE 8.0 WITH ABOVE CUFF SUCTION AID FOUND TO BE CRACKED AND TUBE HAD TO BE REPLACED DUE TO THE FAULT, FOUND DURING USE ON PATIENT. MEDICATION WAS NOT BEING USED WITH THIS PRODUCT. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS PATIENT USE, WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319866 ↗
• MalfunctionMay 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF EXHIBITED A LEAK DURING USE AND DID NOT INFLATE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115869 ↗
• MalfunctionNov 5, 2024Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE CANNULA WAS CRACKED AND BREAKING. THIS OCCURRED WITH 2 CANNULAS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610492 ↗
• MalfunctionJun 14, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE DOCTOR IN CHARGE OF THE PROCEDURE FELT THAT THE BALLOON CAME WITH HOLES. IT'S UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR ANY INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17131270 ↗
• MalfunctionJun 14, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED, THAT THE DOCTOR IN CHARGE OF THE PROCEDURE FELT THAT THE BALLOON CAME WITH HOLES. IT'S UNKNOWN, IF THERE WAS PATIENT INVOLVEMENT OR ANY INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17131147 ↗
• InjuryMar 13, 2023Fluid/Blood Leak; Unintended Deflation; Fluid/Blood Leak; Unintended Deflation

  IT WAS REPORTED THAT THE CUFF FAILED WITHIN APPROXIMATELY 2 WEEKS OF USING THE TRACH TUBE. TUBE WAS CHANGED. NO INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16533510 ↗
• InjuryMar 13, 2023Fluid/Blood Leak; Unintended Deflation; Fluid/Blood Leak; Unintended Deflation

  IT WAS REPORTED THAT AFTER 14 DAYS IN USE, DURING SUCTION THE CUFF SOMETIMES DEFLATED AND EVENTUALLY FLUID GOT INTO THE CUFF. THE TUBE WAS REPLACED. NO INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16532893 ↗
• InjuryNov 4, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PATIENT'S TRACHEOSTOMY CUFF WAS DEFLATING WITHIN 15MINS. RE-INFLATION OF THE CUFF WAS NOT EFFECTIVE FOR THE POST DECUFFING REGIME. EARLY INTERVENTION WAS REQUIRED. THE PATIENT WAS FASTED FOR AN URGENT TRACHEOSTOMY CHANGE.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15737851 ↗
• MalfunctionNov 4, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CLINICIAN IS REPORTING THAT LUER CHECK VALVE FOR INFLATING THE CUFF GETS STUCK AND AIR FROM THE CUFF IS LEAKING. DISCOVERED DURING PRE-CHECK. NO PATIENT INJURY. NO MEDICAL INTERVENTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735322 ↗
• MalfunctionNov 4, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CLINICIAN IS REPORTING THAT LUER CHECK VALVE FOR INFLATING THE CUFF GETS STUCK AND AIR FROM THE CUFF IS LEAKING. DISCOVERED DURING PRE-CHECK. NO PATIENT INJURY. NO MEDICAL INTERVENTION. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15733835 ↗
• MalfunctionOct 25, 2022Inflation Problem; Defective Component; Inflation Problem; Defective Component

  IT WAS REPORTED THAT THE INFLATION BALLOON WAS DEFECTIVE ON THE TRACH TUBE. MORE INFORMATION HAS BEEN REQUESTED, HOWEVER NO FURTHER DETAILS HAVE BEEN PROVIDED AT THIS TIME. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668787 ↗
• MalfunctionOct 24, 2022Device Fell; Device Fell

  IT WAS REPORTED THAT THE CUFF CAME OFF BY LOOSEN ALONE, AND FELL TO THE GROUND, AFTER INHALATION. PATIENT STATED THAT IT WAS NOT PULLED. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663300 ↗
• MalfunctionSep 30, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A CUSTOMER NOTICED THAT 2 TRACHES WERE DEFLATING WITHIN 20 DAYS OF USE. THE CUFF CONTINUES TO DEFLATE. THE CUSTOMER STATED IT APPEARS TO BE AN ISSUE WITH THE INFLATION VALVE AS THE PRESSURE HOLDS WHEN WE CONNECT IT TO AN EXTENSION TUBE WITH A MANOMETER BUT WITHOUT THIS PRESSURE ON THE VALVE IT DEFLATES CONSTANTLY. I HAVE ALSO NOTICED ON REMOVAL THERE IS A SMALL AMOUNT OF WATER WITHIN THE CUFF. NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521537 ↗
• MalfunctionSep 30, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A CUSTOMER NOTICED THAT 2 TRACHES WERE DEFLATING WITHIN 20 DAYS OF USE. THE CUFF CONTINUES TO DEFLATE. THE CUSTOMER STATED IT APPEARS TO BE AN ISSUE WITH THE INFLATION VALVE AS THE PRESSURE HOLDS WHEN WE CONNECT IT TO AN EXTENSION TUBE WITH A MANOMETER BUT WITHOUT THIS PRESSURE ON THE VALVE IT DEFLATES CONSTANTLY. I HAVE ALSO NOTICED ON REMOVAL THERE IS A SMALL AMOUNT OF WATER WITHIN THE CUFF. NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15521488 ↗
• MalfunctionSep 21, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE HAD NO END CAP OF PILOT BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461109 ↗
• MalfunctionMay 21, 2022Fluid/Blood Leak; Material Perforation; Fluid/Blood Leak; Material Perforation

  IT WAS REPORTED THE TRACH TUBE CUFF PRESENTED WITH A DEFECT, UPON INITIAL PLACEMENT IN PATIENT. THE TEAM OF THORACIC SURGERY SPECIALISTS TRIED PRODUCT RESCUE MANEUVERS, SUCH AS CUFF OCCLUSION (BALLOON). IT IS UNCLEAR IF THE RESCUE MANEUVER WAS SUCCESSFUL OR IF A NEW PRODUCT HAD TO BE USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14465863 ↗
• InjuryMay 10, 2022Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  IT WAS REPORTED THERE IS A VISIBLE SPLIT IN THE CUFF'S SUCTION PORT WHILE USING A LUER LOCK SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345756 ↗
• InjuryApr 25, 2022Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT HAD A LEAKING TRACHEOSTOMY TUBE CUFF. THE PATIENT REQUIRED AN EARLIER TRACHEOSTOMY CHANGE. UPON DECANNULATION, THE HCP NOTED THAT A 'BUILD OF BUBBLE' WAS NOTED WITHIN THE CUFF. NO INJURY TO THE PATIENT.

  Patient problems: Ventilator Dependent

  MAUDE report 14193983 ↗
• MalfunctionApr 20, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE WRONG PRODUCT SIZE IN THE PACKAGE. LABEL IS NO8.5 BUT THE PRODUCT IN THE PACKAGE IS NO7.5.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159985 ↗
• MalfunctionApr 18, 2022Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT THE SUCTION LINE IS CLOGGED. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137977 ↗