Portex 101/860/070CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 15019517076134), received between Jun 28, 2021 and Jul 31, 2026 — classified as 3 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (18 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50098346 ↗
• MalfunctionJun 10, 2026Crack

  IT WAS REPORTED THAT AFTER ONE WEEK OF USE, CRACKING WAS OBSERVED AT THE OPENING OF THE SUBGLOTTIC CHANNEL WHERE THE SYRINGE CONNECTS, REQUIRING REPLACEMENT OF THE CANNULA. THE PATIENT WAS INVOLVED, BUT NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25462924 ↗
• MalfunctionMar 9, 2026Gas/Air Leak

  IT WAS REPORTED THAT APPROXIMATELY 3.5 HOURS AFTER THE TUBE WAS REPLACED, THE CUFF-LEAK ALARM ACTIVATED. AFTER EXTUBATING AND IMMERSION IN NORMAL SALINE, AN AIR LEAK FROM THE CUFF WAS CONFIRMED. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24551690 ↗
• MalfunctionJan 28, 2026Material Separation

  IT WAS REPORTED THAT THE RED ONE-WAY VALVE ON THE PILOT BALLOON CAME OFF. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201538 ↗
• MalfunctionOct 21, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TUBE EXHIBITED A LEAKAGE. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23350844 ↗
• MalfunctionFeb 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PILOT BALLOON WAS OUT OF THE INFLATION LINE. THE EVENT OCCURRED IN JAN-2025 IN THE FACILITY. THIS OCCURRED DURING PATIENT USE, BUT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356253 ↗
• MalfunctionJan 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE "THE PILOT BALLOON CAME OFF THE INFLATION LINE." THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160224 ↗
• MalfunctionJan 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "AS THE PILOT BALLOON CAME OUT OF THE INFLATION LINE AT THE TIME OF REPLACEMENT, IT WAS QUICKLY REPLACED WITH A NEW ONE AND NO SERIOUS PROBLEM OCCURRED." THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081916 ↗
• MalfunctionSep 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS DRAINING AIR. THIS OCCURRED DURING PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305894 ↗
• MalfunctionSep 10, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE BAG-SHAPED PART AND THE TUBE CONNECTED TO IT COME OFF, SO THE CUFF PRESSURE WON'T APPLY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181231 ↗
• MalfunctionJun 17, 2024Leak/Splash; Material Puncture/Hole; Gas/Air Leak; Leak/Splash; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT USE WAS DISCONTINUED DUE TO A HOLE IN THE CUFF WHICH PREVENTED AIR FROM ENTERING THE CUFF. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546935 ↗
• MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE OPERATOR TRIED TO PUSH AIR IN THE PILOT BALLOON, THE PILOT BALLOON CAME OFF. THIS OCCURRED UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359349 ↗
• MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE OPERATOR TRIED TO PUSH AIR IN THE PILOT BALLOON, THE PILOT BALLOON CAME OFF. THIS OCCURRED UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359303 ↗
• MalfunctionApr 5, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK IS OCCURRING. THIS OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053530 ↗
• MalfunctionApr 2, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT ¿THE CANNULA WAS APPLIED TO THE PATIENT ON (B)(6) 2024 AND THE MEDICAL PERSONAL SAW ON (B)(6) 2024 THAT THE CANNULA IS FAULTY. WHEN ASKED HOW THE PATIENT WAS AFFECTED OR IF THERE WAS HARM, THE USER FACILITY REPORTED: "IT IS HARD TO SAY IF THE PATIENT WAS INJURED. THERE HAVE PROBABLY BEEN OCCASIONS WHEN YOU HAVE NOT BEEN ABLE TO ASPIRATE MUCUS IN THE SUBGLOTTIC CANAL BECAUSE YOU DID NOT NOTICE THE AIR LEAK." THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR INVESTIGATION. THE EVENT WAS RESOLVED WITH A NEW TRACH TO REPLACE THE MALFUNCTIONING ONE. THERE WAS NO UN-PLANNED OR EMERGENT TRACH CHANGE. THE CHANGE WAS PLANNED.

  Patient problems: Insufficient Information

  MAUDE report 19021150 ↗
• MalfunctionMar 12, 2024Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE CUFF AND THE CUFF DID NOT INFLATE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886287 ↗
• MalfunctionFeb 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT "USE WAS DISCONTINUED DUE TO DISCOMFORT WHEN AIR WAS ADDED TO THE CUFF". THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18803649 ↗
• MalfunctionNov 29, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, THE DEVICE HAD A CUFF AIR LEAK. AIR WAS LEAKING FROM THE PILOT BALLOON CONNECTION PORT. AFTER ABOUT 40 MINUTES THE CUSTOMER WAS NO LONGER ABLE TO FEEL ANY PRESSURE IN THE PILOT BALLOON. ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18231990 ↗
• InjuryNov 2, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TUBE WAS INSERTED AFTER TRACHEOSTOMY. THERE WAS VOICE LEAKAGE, AND WHEN CHECKING THE AIR SEVERAL TIMES, IT WAS GRADUALLY DECREASING. REPLACED THE TUBE WITH A NEW ONE. ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18057085 ↗
• MalfunctionOct 19, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN AIR LEAK WAS OBSERVED FROM THE CUFF WHILE USING A TRACHEOSTOMY TUBE IN THE ICU. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17967239 ↗
• MalfunctionAug 29, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD A SUSPECTED CUFF LEAK. ALARMS OCCUR FREQUENTLY DURING PATIENT USE. THE PRODUCT WAS USED IN PATIENTS WITH THICK NECKS, ITS EFFECTS WERE ALSO SUSPECTED. THERE HAS BEEN NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 17646152 ↗
• MalfunctionAug 21, 2023Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  IT WAS REPORTED THAT THE INFLATION WAS REMOVED WHEN THE TRACHEOSTOMY TUBE WAS REPLACED. IT WAS NOT TORN. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17591782 ↗
• MalfunctionJul 20, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK FROM THE CUFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368428 ↗
• MalfunctionJul 10, 2023Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT WHEN AIR WAS PUT INTO THE CUFF, AIR LEAKAGE OCCURS AND THE CUFF DEFLATES. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17289831 ↗
• MalfunctionJun 30, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE PRODUCT WAS INTUBATED INTO THE PATIENT, LEAKAGE OF AIR FROM IT WAS OBSERVED. THE CUSTOMER SUSPECTED THE CUFF MAY HAVE BEEN DAMAGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17240486 ↗