Portex 100/897/090CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15019315107214), received between Apr 26, 2018 and May 15, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Disconnection

  IT WAS REPORTED THAT THE 15MM CONNECTOR WHICH ALLOWS STERI-CATH AND VENTILATOR TUBING TO CONNECT DIRECTLY TO THE VENTILATOR BECAME DISCONNECTED FROM THE SILICONE TRACHEOSTOMY TUBING. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT AND IT AFFECTED PATIENT CARE. THE ISSUE WAS RESOLVED, MEDICAL INTERVENTION WAS REQUIRED, THE TUBE WAS REMOVED AND A NEW TRACHEOSTOMY INSERTED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183043 ↗
• MalfunctionMay 14, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE LEAKED WHEN INFLATED. THE DATE OF THE EVENT WAS (B)(6) 2024 AT 10:30. THE EVENT OCCURRED DURING USE ON PATIENT FOR LESS THAN 10 MINUTES. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021788 ↗
• MalfunctionFeb 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A CLINICIAN DID A PRE-INSERTION CHECK OF CUFF AND IT WAS FOUND THAT THE CUFF FAILED UNDER INFLATED PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366442 ↗
• MalfunctionFeb 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE LEAKED WHEN INFLATED. THE DATE OF THE EVENT WAS (B)(6) 2024 AT 10:30. THE EVENT OCCURRED DURING USE ON PATIENT FOR LESS THAN 10 MINUTES. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366435 ↗
• MalfunctionJan 18, 2024Crack; Crack

  IT WAS REPORTED THAT "THEY PLACE THE UNIPERC WHICH IMMEDIATELY LEAKS". (THIS PRODUCT MALFUNCTION REPORTED UNDER (B)(6). THEY EXAMINE ANOTHER ONE, WHICH HAS A CRACK IN IT. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536475 ↗
• MalfunctionJan 17, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "THEY PLACE THE UNIPERC WHICH IMMEDIATELY LEAKS. THEY EXAMINE ANOTHER ONE, WHICH HAS A CRACK IN IT (THIS PRODUCT MALFUNCTION REPORTED UNDER (B)(4). THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT REPORTED. UPDATE: GCM RECEIVED AN EMAIL FROM KATHRIN KRONLUND ON 19-DEC-2023 IN WHICH STATES THAT THERE WERE 2 PRODUCTS INVOLVED WITH LOT NUMBER 3986056 AND LOT NUMBER 4013580 AND CONFIRMED THE PICK-UP ADDRESS. LHOLHOS 19-DEC-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530019 ↗
• InjuryOct 11, 2022Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  IT WAS REPORTED THAT THE END CONNECTOR OF THE TRACH TUBE WAS FOUND BY STAFF TO BE DETACHING ITSELF FROM THE MAIN BODY OF THE TUBE. THE TUBE WAS CHANGED ON THE UNIT. ADDITIONAL INFORMATION WAS RECEIVED VIA CUSTOMER RESPONSE EMAIL (B)(6) 2022 STATING THE END OF CONNECTOR DETACHED ITSELF FROM MAIN UNIT AND THE PATIENT'S BODY WAS WARM TO THE TOUCH. THE SITUATION WAS RESOLVED BY CHANGING THE TRACHEOSTOMY TUBE TO ANOTHER ONE OF THE SAME SIZE AND TYPE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15574671 ↗
• InjuryApr 11, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT UNIPERC AN UNPLANNED TRACH CHANGE WAS NEEDED DUE TO A LEAK, ISSUE APPEARED TO BE RELATED TO POSITIONING OF TUBE. IT WAS REPORTED THE PATIENT WAS INTUBATED ORALLY AND TRACHE TUBE REMOVED. THEN INSERTED A NEW 9.0 UNIPERC ADJUSTABLE FLANGE TRACHE (CHECKED FOR LEAKS PRIOR TO INSERTION) CUFF PRESSURE CHECKED 32CM H20 PRESSURE. PRIOR TO THIS IT WAS REPORTED THE TRACHE STOMA WAS MADE LARGER BY TRIMMING 3RD TRACHEAL RING.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11646859 ↗
• MalfunctionDec 21, 2020Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL UNI PERC SIZE 9 ADJUSTABLE FLANGE TRACHEOSTOMY WAS INSERTED IN PATIENT ON (B)(6) 2020. ON (B)(6) 2020 THE CONNECTOR (WHITE SECTION THAT VENTILATOR CIRCUIT ATTACHES TO) SEPARATED FROM THE TUBE. AS A RESULT TRACHEOSTOMY CHANGE REQUIRED. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11048180 ↗
• MalfunctionDec 20, 2018Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION WAS RECEIVED THAT A TRACHEOSTOMY (TRACH) CHANGE OUT WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8186332 ↗
• InjuryMay 10, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF COULD NOT MAINTAIN ENOUGH PRESSURE FOR VENTILATION. IN ADDITION, REMOVAL WAS MADE DIFFICULT DUE TO THE CUFF NOT DEFLATING. ATTEMPTS TO INFLATE/DEFLATE WITH A SYRINGE RESULTED ONLY IN INFLATING/DEFLATING THE BLUE PILLOW. THERE WAS NO AIR ENTRY OR EXIT FROM THE CUFF. THE INITIAL REPORTER STATED THAT THERE WAS A QUERY VALVE MALFUNCTION. THE AFOREMENTIONED ISSUES OCCURRED 13 HOURS AFTER THE TRACHEOSTOMY TUBE WAS PLACED. THE INITIAL REPORTER ALSO NOTED THAT THERE WAS "POTENTIAL TRAUMA CAUSED TO TRACHEA, BUT THIS WAS NOT OBSERVABLE." AN INVESTIGATION WAS PERFORMED INTO THE INCIDENT ABOVE BY THE FACILITY. THE INVESTIGATION WAS UNABLE TO CONFIRM THE COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503691 ↗
• MalfunctionMay 10, 2018Decrease in Pressure; Decrease in Pressure

  USER FACILITY REPORTED THAT A TRACHEOSTOMY TUBE CUFF FAILED TO MAINTAIN SUFFICIENT PRESSURE FOR ADEQUATE VENTILATION ON VENTILATOR. INFORMATION INDICATES THE CUFF BALLOON DEFLATED AS SOON AS IT WAS PUMPED UP WITH A PRESSURE MANOMETER. THE TRACHEOSTOMY TUBE HAD BEEN IN SITU FOR 5 DAYS PRIOR TO DEPLOYING THE CUFF. BEFORE REMOVING, THE NEEDLE INDICATED THE PRESSURE DECREASED RAPIDLY EVEN WHILE ATTEMPTING TO PUMP UP THE CUFF. AFTER REMOVAL, THE MANOMETER SHOWED THE SAME LOSS OF PRESSURE ALTHOUGH PRESSURE REDUCED AT A SLOWER RATE THAN WHEN DEPLOYED IN THE TRACHEA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7503690 ↗
• MalfunctionApr 26, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "BALLOON LOST TAUTNESS SLOWLY AFTER INFLATION" AFTER INTUBATION. NO SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7466047 ↗