Portex 101/870/090CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 15019517076240), received between Feb 27, 2021 and Dec 20, 2023 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2023Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS MALFUNCTIONING DURING USE. THE ISSUES INCLUDE THE MALFUNCTIONING OF THE SUBGLOTTIC SUCTION VALVE ON THE NEWLY INSERTED TRACHEOSTOMY TUBE. ADDITIONALLY, THE CUFF OF THE TRACHEOSTOMY TUBE EXHIBITED IMMEDIATE LEAKAGE AFTER INSERTION. THIS PROMPTED THE NEED FOR MULTIPLE TUBE CHANGES. THIS SITUATION IS OF PARTICULAR CONCERN AS THE PATIENT UNDERGOING THESE CHANGES IS AT HIGH RISK OF ASPIRATION. IT WAS REPORTED THAT THE FOLLOWING MEASURES WERE TAKEN IN ORDER TO "SOLVE THE PROBLEM: TK CHANGE, SURVEY OF LABORATORY PARAMETERS AND ANTIBIOSIS." THERE WAS PATIENT INVOLVEMENT. THE SAMPLES ARE NOT AVAILABLE FOR EVALUATION. THE PRODUCTS WERE FOUND TO BE DEFECTIVE BETWEEN 1-NOV-2023 AND 14-NOV-2023. ONLY ONE PATIENT WAS INVOLVED. (PATIENT IDENTIFIER (B)(6).

  Patient problems: Aspiration Pneumonitis; Insufficient Information

  MAUDE report 18365602 ↗
• InjuryDec 20, 2023Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS MALFUNCTIONING DURING USE. THE ISSUES INCLUDE THE MALFUNCTIONING OF THE SUBGLOTTIC SUCTION VALVE ON THE NEWLY INSERTED TRACHEOSTOMY TUBE. ADDITIONALLY, THE CUFF OF THE TRACHEOSTOMY TUBE EXHIBITED IMMEDIATE LEAKAGE AFTER INSERTION. THIS PROMPTED THE NEED FOR MULTIPLE TUBE CHANGES. THIS SITUATION IS OF PARTICULAR CONCERN AS THE PATIENT UNDERGOING THESE CHANGES IS AT HIGH RISK OF ASPIRATION. IT WAS REPORTED THAT THE FOLLOWING MEASURES WERE TAKEN IN ORDER TO "SOLVE THE PROBLEM: TK CHANGE, SURVEY OF LABORATORY PARAMETERS AND ANTIBIOSIS." THERE WAS PATIENT INVOLVEMENT. THE SAMPLES ARE NOT AVAILABLE FOR EVALUATION. THE PRODUCTS WERE FOUND TO BE DEFECTIVE BETWEEN 1-NOV-2023 AND 14-NOV-2023. ONLY ONE PATIENT WAS INVOLVED. (PATIENT IDENTIFIER (B)(6).

  Patient problems: Aspiration Pneumonitis; Insufficient Information

  MAUDE report 18365599 ↗
• InjuryDec 20, 2023Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS MALFUNCTIONING DURING USE. THE ISSUES INCLUDE THE MALFUNCTIONING OF THE SUBGLOTTIC SUCTION VALVE ON THE NEWLY INSERTED TRACHEOSTOMY TUBE. ADDITIONALLY, THE CUFF OF THE TRACHEOSTOMY TUBE EXHIBITED IMMEDIATE LEAKAGE AFTER INSERTION. THIS PROMPTED THE NEED FOR MULTIPLE TUBE CHANGES. THIS SITUATION IS OF PARTICULAR CONCERN AS THE PATIENT UNDERGOING THESE CHANGES IS AT HIGH RISK OF ASPIRATION. IT WAS REPORTED THAT THE FOLLOWING MEASURES WERE TAKEN IN ORDER TO "SOLVE THE PROBLEM: TK CHANGE, SURVEY OF LABORATORY PARAMETERS AND ANTIBIOSIS." THERE WAS PATIENT INVOLVEMENT. THE SAMPLES ARE NOT AVAILABLE FOR EVALUATION. THE PRODUCTS WERE FOUND TO BE DEFECTIVE BETWEEN 1-NOV-2023 AND 14-NOV-2023. ONLY ONE PATIENT WAS INVOLVED. (PATIENT IDENTIFIER (B)(6).

  Patient problems: Aspiration Pneumonitis; Insufficient Information

  MAUDE report 18365528 ↗
• InjuryDec 20, 2023Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS MALFUNCTIONING DURING USE. THE ISSUES INCLUDE THE MALFUNCTIONING OF THE SUBGLOTTIC SUCTION VALVE ON THE NEWLY INSERTED TRACHEOSTOMY TUBE. ADDITIONALLY, THE CUFF OF THE TRACHEOSTOMY TUBE EXHIBITED IMMEDIATE LEAKAGE AFTER INSERTION. THIS PROMPTED THE NEED FOR MULTIPLE TUBE CHANGES. THIS SITUATION IS OF PARTICULAR CONCERN AS THE PATIENT UNDERGOING THESE CHANGES IS AT HIGH RISK OF ASPIRATION. IT WAS REPORTED THAT THE FOLLOWING MEASURES WERE TAKEN IN ORDER TO "SOLVE THE PROBLEM: TK CHANGE, SURVEY OF LABORATORY PARAMETERS AND ANTIBIOSIS." THERE WAS PATIENT INVOLVEMENT. THE SAMPLES ARE NOT AVAILABLE FOR EVALUATION. THE PRODUCTS WERE FOUND TO BE DEFECTIVE BETWEEN 1-NOV-2023 AND 14-NOV-2023. ONLY ONE PATIENT WAS INVOLVED. (PATIENT IDENTIFIER (B)(6).

  Patient problems: Aspiration Pneumonitis; Insufficient Information

  MAUDE report 18365508 ↗
• InjuryDec 13, 2023Component Incompatible; Inflation Problem; Gas/Air Leak; Component Incompatible; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE HEALTH PROFESSIONAL EXPERIENCED ISSUES DURING USE WITH A PATIENT. THE ISSUES INCLUDE THE MALFUNCTIONING OF THE SUBGLOTTIC SUCTION VALVE ON THE NEWLY INSERTED TRACHEOSTOMY TUBE. ADDITIONALLY, THE CUFF OF THE TRACHEOSTOMY TUBE EXHIBITED IMMEDIATE LEAKAGE AFTER INSERTION, "PROMPTING THE NEED FOR MULTIPLE TUBE CHANGES". THIS SITUATION IS OF PARTICULAR CONCERN AS THE PATIENT UNDERGOING THESE CHANGES IS AT HIGH RISK OF ASPIRATION. AN UNUSED SAMPLE FROM THE SAME LOT IS AVAILABLE FOR INVESTIGATION. THE EVENT HAS AFFECTED THE PATIENT CARE AND A MEDICAL INTERVENTION WAS NECESSARY. DESCRIPTION OF THE MEDICAL INTERVENTION: THE CLIENT STATED ONLY "TK CHANGE, SURVEY OF LABORATORY PARAMETERS, AND ANTIBIOSIS". THE EVENT HAS OCCURRED IN HOSPITAL. IT IS UNKNOWN IF THERE WAS AN INJURY OR NOT. "4 OR 5 SAMPLES ARE AFFECTED. HOWEVER ONLY ONE SAMPLE OF THE SAME LOT NUMBER IS AVAILABLE FOR INVESTIGATION." PRODUCTS WERE AFFECTED DURING 01-NOV-2023 AND 14-NOV-2023, THEREFORE NO EXACT DATES COULD BE PROVIDED. A1: ONE PATIENT, AND FIVE PRODUCT MALFUNCTIONS WERE REPORTED. (B)(6) BOTH REPRESENT THE SAME PATIENT. THIS IS THE FIRST MALFUNCTION REPORT FOR THE RELATED COMPLAINTS.

  Patient problems: Aspiration Pneumonitis; Insufficient Information

  MAUDE report 18321024 ↗
• MalfunctionDec 22, 2022Disconnection; Gas/Air Leak; Disconnection; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM IT WAS OBSERVED. THE CUSTOMER CHECKED THE PRODUCT AND THE PILOT BALLOON WAS FOUND DETACHED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040357 ↗
• MalfunctionFeb 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS DETECTED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506638 ↗
• MalfunctionFeb 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF FLUID BETWEEN THE PILOT BALLOON AND THE INFLATION LINE WAS FOUND. THE CUSTOMER THEN STOPPED USING THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506092 ↗
• MalfunctionJun 24, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY CUFF WAS LEAKING AIR FROM THE CUFF. THERE WAS NO PATIENT INJURY AND NO REPORTED ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059746 ↗
• MalfunctionFeb 27, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER CONFIRMED IN A PRE-USE CHECK THAT THE PRODUCT WORKED PROPERLY. HOWEVER, THREE (3) DAYS AFTER INDWELLING IT IN THE PATIENT, THE CUSTOMER NOTICED THE INFLATION LINE WAS TORN OFF, CAUSING LEAKAGE OF AIR FROM THE PRODUCT TO OCCUR. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 11390642 ↗