Portex 101/870/070CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 15019517076202), received between Apr 19, 2021 and Feb 18, 2026 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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.

• MalfunctionFeb 18, 2026Crack

  IT WAS REPORTED THAT THE PATIENT CAME IN FOR A TRACHY CHANGE AND NOTED A HAIRLINE CRACK IN THE IN-LINE SUCTION AID TIP WHEN SYRINGE WAS INSERTED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378931 ↗
• MalfunctionDec 29, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE CUFF PRESSURE DID NOT INCREASE. THE REPORTER NOTED THAT REPLACEMENT WAS SCHEDULED FOR ONE MONTH ON 10/21, BUT THE CUFF PRESSURE DID NOT INCREASE ON 11/7, SO IT WAS REPLACED. THEN, ON 11/28, THE CUFF PRESSURE DID NOT INCREASE EITHER, SO IT WAS REPLACED AGAIN. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT PATIENT'S HOME. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919024 ↗
• MalfunctionDec 29, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE CUFF PRESSURE DID NOT INCREASE. THE REPORTER NOTED THAT REPLACEMENT WAS SCHEDULED FOR ONE MONTH ON 10/21, BUT THE CUFF PRESSURE DID NOT INCREASE ON 11/7, SO IT WAS REPLACED. THEN, ON 11/28, THE CUFF PRESSURE DID NOT INCREASE EITHER, SO IT WAS REPLACED AGAIN. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT PATIENT'S HOME. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919023 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF PRESSURE COULD NOT BE KEPT. THERE WAS A POSSIBILITY OF AN AIR LEAK. THE EVENT OCCURRED DURING THE PATIENT USE, AND NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877517 ↗
• MalfunctionJul 18, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A ROUTINE ASSESSMENT, THE CUFF WAS FOUND TO HAVE DEFLATED TO APPROXIMATELY 10¿15 CMH2O PRESSURE, DESPITE BEING INFLATED EARLIER IN THE SHIFT. A TRACHEOSTOMY TUBE CHANGE WAS PERFORMED DUE TO CONCERNS ABOUT POTENTIAL SILENT ASPIRATION. THE EXISTING PORTEX 7.0 CUFFED SUCTION TRACHEOSTOMY TUBE WAS REPLACED WITH A SIMILAR-SIZED TUBE. THE EVENT OCCURRED DURING THE TRACHEOSTOMY ROUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22544206 ↗
• MalfunctionJun 25, 2025Crack; Crack

  IT WAS REPORTED THAT THE TUBE CRACKED ABOVE THE CUFF SUCTIONAID AND WAS NOT ABLE TO SUCTION THE PATIENT. THERE WAS A TRACHEOSTOMY CHANGE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331343 ↗
• InjuryJun 24, 2025Crack; Crack

  IT WAS REPORTED THAT THE DEVICE INSERTED ON (B)(6) 2025 WAS FOUND TO BE FAULTY. THE TUBE CRACKED WHEN A 10ML SYRINGE WAS INSERTED, AN ISSUE THAT OCCURRED MULTIPLE TIMES RECENTLY. THIS REQUIRED AN URGENT TUBE CHANGE AND THE USE OF DEVICE TO PREVENT INFECTION FOR THE PATIENT. A FAULTY SUBGLOTTIC PORT WAS IDENTIFIED DURING AN OUTPATIENT VISIT, AND THE PATIENT SHOWED INCREASED SECRETIONS AND RISK OF ASPIRATION. A TRACHEOSTOMY TUBE CHANGE WAS CARRIED OUT TO ENSURE SAFE AIRWAY MANAGEMENT. THE ISSUE WAS NOW RESOLVED WITH A NEW TRACHEOSTOMY TUBE.

  Patient problems: Salivary Hypersecretion

  MAUDE report 22318597 ↗
• MalfunctionJun 2, 2025Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT THERE HAVE BEEN PROBLEMS WITH CUFF LEAKAGE. IT SEEMS TO BE AN ISSUE WITH THE VALVES TO THE CUFF TUBE. WHEN THE CUFF PRESSURE GAUGE IS CONNECTED IT SEEMS TO WORK, BUT WHEN DISCONNECTED, A LEAKAGE OCCURS. THE CUFFS THEMSELVES DO NOT SEEM DEFECTIVE. THERE HAVE BEEN SEVERAL PATIENTS WHO HAD TO BE CHANGED FREQUENTLY DUE TO THIS REASON. THE CANNULAS THAT WERE REPLACED EARLIER HAVE BEEN RETAINED AND CUFFED OVERNIGHT WITHOUT ANY LEAKAGE. THEY LOSE 5-10 CM H2O WHEN CONNECTED TO THE CUFF PRESSURE GAUGE, BUT IT SEEMS TO BE A KNOWN ISSUE. IN SOME CASES, THE WARD STUFF, KEPT THE CUFF PRESSURE GAUGE CONNECTED CONSTANTLY. IT IS BELIEVED THAT THIS CONCERNS OPERATIONAL ERRORS. PHOTO OF THE SAMPLE HAS BEEN PROVIDED. THERE WAS PATIENT INVOLVEMENT. ASSOCIATED COMPLAINT DOCUMENTED (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126466 ↗
• MalfunctionMay 2, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SUCTION LINE CRACKED DURING USE ON THE PATIENT. SOMEONE BECAME AWARE OF THE ISSUE WHEN STAFF NOTICED PATIENT BLEEDING OUT INTO THE BED. THE PRODUCT WAS NOT REPROCESSED OR RE-STERILIZED PRIOR TO USE. THE PRODUCT WAS NOT CONTAMINATED NOR CONTAINED A BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THERE WAS DELAY IN THERAPY, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950778 ↗
• MalfunctionMar 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE OPERATOR WENT TO CHECK ON THE PATIENT BECAUSE THE LOW-PRESSURE ALARM ON THE RESPIRATOR WAS SOUNDING AND FOUND THAT THE CUFF TIP HAD COME OFF. THE OPERATOR REPLACED THE TUBE ON THE SPOT. THE EVENT OCCURRED AT THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21573140 ↗
• MalfunctionFeb 25, 2025Crack; Connection Problem; Crack; Connection Problem

  IT WAS REPORTED THAT THE CONNECTION PART ON SUCTION LINE CRACKED. THERE WERE UNKNOW PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463847 ↗
• MalfunctionNov 14, 2024Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  IT WAS STATED THAT THE PILOT BALLOON WENT OUT OF LINE OF INFLATION WHILE THIS DEVICE WAS IN USE ON THE PATIENT. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THE SAMPLE WAS AVAILABLE FOR RETURN. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20685639 ↗
• MalfunctionMay 6, 2024Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT: ¿WE HAVE FOUND ON TWO (2) OCCASIONS THAT THE TUBE BALLOON CUFF HAS NOT STAYED INFLATED ON BOTH OCCASIONS THEREFORE HAVE BEEN FAULTY.¿ PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19255750 ↗
• MalfunctionJan 26, 2024Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE, AND EVEN IF IT DID, AIR WOULD ESCAPE WHEN THE PILOT BALLOON WAS PRESSED. THE EVENT OCCURRED DURING PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586856 ↗
• MalfunctionNov 29, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED BY THE WAREHOUSE THAT THE ITEM HAS ERROR IN "EAN" CODE ON THE INDIVIDUAL PRODUCT PACKAGING. THE CODE READS AS 20PCS INSTEAD OF 1PC. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18234424 ↗
• MalfunctionNov 1, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER INSERTING THE TRACHEOSTOMY, THE CUFF WAS INFLATED, BUT AIR LEAKAGE WAS CONFIRMED. PATIENT ADVERSE EFFECTS AND EVENT OUTCOME ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18051609 ↗
• MalfunctionSep 29, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT APPROXIMATELY TWELVE DAYS AFTER THE TRACHEOSTOMY TUBE WAS PLACED THE PILOT BALLOON FELL OFF. WHEN AIR WAS INJECTED THROUGH THE PILOT BALLOON, IT FELL OFF. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17847510 ↗
• MalfunctionAug 15, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT NO ABNORMALITY WAS FOUND IN THE PRE-USE CHECK. THEN A CUFF LEAK WAS FOUND AFTER THE PATIENT WAS INTUBATED. ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17552682 ↗
• MalfunctionMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER HAVING THE PATIENT IN A BATH, THE CUSTOMER LAID THE PATIENT DOWN IN THE BED. THE CUSTOMER THEN NOTICED THE PILOT BALLOON WAS DETACHED FROM THE PRODUCT. SHE THEN BONDED THE PILOT BALLOON TO THE INFLATION LINE BY HERSELF USING ADHESIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873129 ↗
• MalfunctionMay 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER HAVING THE PATIENT IN A BATH, THE CUSTOMER LAID THE PATIENT DOWN IN THE BED. THE CUSTOMER THEN NOTICED THE PILOT BALLOON WAS DETACHED FROM THE PRODUCT. SHE THEN BONDED THE PILOT BALLOON TO THE INFLATION LINE BY HERSELF USING ADHESIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873118 ↗
• InjuryJan 10, 2023Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PILOT BALLOON GOT DETACHED FROM THE INFLATION LINE, AND THE CUFF WAS FOUND DEFLATED. NO PATIENT INJURY REPORTED. THE REPORTED LOT NUMBER COULDN'T BE VERIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129857 ↗
• MalfunctionJul 6, 2022Misassembly by Users; Misassembly by Users

  IT WAS REPORTED THAT THE CUSTOMER WAS TAKING OUT THE PRODUCT (TUBE) FROM THE PATIENT FOR REGULAR REPLACEMENT, AND FORGOT TO REMOVE THE OBTURATOR FROM THE PATIENT, WHICH PREVENTED THE CUSTOMER FROM PERFORMING RESPIRATORY VENTILATION ON A TEMPORARY BASIS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14928513 ↗
• MalfunctionMar 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE USE OF THE PRODUCT, THE PILOT BALLOON GOT DETACHED. THE CUSTOMER STATED THIS HAPPENED WITHOUT CONTACT WITH SHARP OBJECTS OR APPLIED PRESSURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13887262 ↗
• MalfunctionJan 7, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT TWENTY-EIGHT (28) DAYS AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER NOTICED THE INFLATION LINE WAS DETACHED FROM THE PILOT BALLOON. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195169 ↗
• MalfunctionJan 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, A TEAR IN THE CUFF WAS OBSERVED. ALSO, THE INFLATION LINE WAS FOUND TORN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172473 ↗