Portex 101/870/075CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 15019517076219), received between Apr 23, 2021 and Sep 25, 2026 — classified as 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50892657 ↗
• MalfunctionSep 10, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50703514 ↗
• MalfunctionJul 2, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING PATIENT USE, WITH BLUSELECT TUBE KITS THE PRESSURE HAD DROPPED FROM 20 TO 10 IN A COUPLE OF HOURS. SPARE CANNULA WAS REPLACED. THERE WAS PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25691932 ↗
• MalfunctionJun 12, 2026Inflation Problem

  IT WAS REPORTED THAT A NEW TRACHEOSTOMY TUBE WAS INSERTED FOR THE PATIENT. AFTER PLACEMENT, IT WAS OBSERVED THAT THE CUFF INFLATION VALVE WAS BROKEN, PREVENTING CUFF INFLATION. THE PATIENT HAD TO WAIT FOR AN ENT (EAR, NOSE, AND THROAT) SPECIALIST TO REPLACE THE CANNULA. IN THE MEANTIME, THE PATIENT WAS MANAGED WITHOUT CUFF INFLATION. THE EVENT OCCURRED IN A HOSPITAL SETTING. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488907 ↗
• MalfunctionJun 12, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE CUSTOMER WENT TO MAKE THE EXCHANGE, THE BALLOON WAS NOT INFLATING, IT WAS PUNCTURED. THERE IS NO REPORT OF PATIENT INVOLVEMENT OR HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194552 ↗
• MalfunctionJun 12, 2025Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE CUSTOMER WENT TO MAKE THE EXCHANGE, THE BALLOON WAS NOT INFLATING, IT WAS PUNCTURED. THERE IS NO REPORT OF PATIENT INVOLVEMENT OR HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194520 ↗
• MalfunctionMay 21, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE WRITING ON THE TRACHEOSTOMY TUBE PILOT BALLOON RUBBED OFF DURING USE DUE TO CLEANING. PATIENT HAD INITIAL TRACHEOSTOMY TUBE INSERTED; HOWEVER, PATIENT SELF-DECANNULATED. THE EVENT TOOK PLACE AT THE HOSPITAL DURING THE ROUTINE TRACH TEAM ROUNDS. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19360663 ↗
• MalfunctionJan 10, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A ROUTINE TRACHE TEAM ROUNDING, IT WAS NOTED THAT THE PILOT BALLOON WRITING WASN'T CLEAR AND HAD RUBBED OFF. THE TRACHEOSTOMY TUBE WAS CHANGED. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489416 ↗
• MalfunctionSep 25, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE PILOT BALLOON WAS REPLACED IN THE MORNING, AND IN THE AFTERNOON OF THE SAME DAY. IT WAS DISCOVERED THAT THE PILOT BALLOON HAD FALLEN OFF, AND USE WAS DISCONTINUED. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17813725 ↗
• MalfunctionMay 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT FOURTEEN (14) DAYS AFTER STARING TO USE THE PRODUCT, THE CUSTOMER NOTICED THE PILOT BALLOON WAS DETACHED FROM THE INFLATION LINE. IT IS UNKNOWN AT WHICH POINT OF THE DAY THE EVENT OCCURRED. NO TROUBLE WAS OBSERVED DURING THE USE OF THE PRODUCT. THERE WERE NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844495 ↗
• InjuryApr 6, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE CUSTOMER CONDUCTED THE PRE-USE AIR LEAK CHECK, NO ANOMALY IN THE CUFF (AND THE PRODUCT) WAS OBSERVED. HOWEVER, DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS DETECTED. A TRACH CHANGE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693908 ↗
• InjuryJan 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE CUSTOMER WAS PERFORMING A SUCTION FOR THE TOP OF THE CUFF, THE SUCTION LINE CONNECTOR GOT DETACHED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129879 ↗
• MalfunctionNov 2, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. THE CUSTOMER PUT AIR IN IT AGAIN, BUT THE LEAKAGE PERSISTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15717225 ↗
• MalfunctionOct 26, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677098 ↗
• MalfunctionJun 15, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT DURING USE OF THE TRACHEAL TUBE, THE INFLATION LINE BROKE. NO ADDITIONAL INFORMATION WAS AVAILABLE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14695678 ↗
• InjuryJun 8, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT IMMEDIATELY AFTER THE CUSTOMER WAS INTUBATED THE ARTIFICIAL RESPIRATOR ISSUED AND AIR LEAK ALARM. THE DEVICE WAS CHANGED TO RESOLVE THE ISSUE. NO PATIENT INJURY. NO FURTHER INFORMATION AVAILABLE FOR THIS COMPLAINT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 14635476 ↗
• MalfunctionApr 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PILOT BALLOON WAS FOUND DETACHED FROM THE INFLATION LINE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167272 ↗
• MalfunctionMar 17, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT, DURING THE USE OF THE PRODUCT, THE INFLATION LINE GOT DETACHED FROM THE PILOT BALLOON. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13793925 ↗
• InjuryMar 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT NO ANOMALY WAS FOUND IN THE PRODUCT DURING THE PRE-USE AIR LEAK CHECK. HOWEVER, SEVEN (7) DAYS AFTER THE CUSTOMER STARTED USING IT, HE NOTICED THE PILOT BALLOON WAS DETACHED FROM THE INFLATION LINE. THE PATIENTS HAD SPONTANEOUS BREATHING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fever

  MAUDE report 13635392 ↗
• MalfunctionFeb 18, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT ONE DAY AFTER THE CUSTOMER STARTING TO USE THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED, WHICH DID NOT ALLOW HIM TO USE IT PROPERLY. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13563353 ↗
• MalfunctionFeb 9, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT ONE WEEK AFTER THE CUSTOMER STARTED TO USE THE PRODUCT, THE INFLATION LINE GOT DETACHED FROM THE PILOT BALLOON. EVENT OF THE SAME NATURE HAS BEEN RECENTLY REPORTED, MAKING THIS THE SECOND OCCURRENCE FOR THE SAME ISSUE (DIFFERENT DEVICES FOR EACH OCCURRENCE). NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497470 ↗
• MalfunctionJan 28, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE PILOT BALLOON GOT DETACHED FROM THE INFLATION LINE. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13388317 ↗
• MalfunctionDec 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE INFLATION LINE WAS LOOSENED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122249 ↗
• MalfunctionDec 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING USE, THE PILOT BALLOON GOT DETACHED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

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

  MAUDE report 13112934 ↗
• MalfunctionDec 23, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUSTOMER REPLACED THE PRODUCT WITH A NEW ONE IN THE MORNING AND IT WORKED PROPERLY FOR A WHILE. IN THE AFTERNOON HOWEVER, HE NOTICED CUFF'S AIR PRESSURE WOULD NOT GO UP. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078232 ↗