Portex 198-35LRecalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 15019315058615), received between Mar 13, 2017 and Nov 13, 2025 — classified as 6 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS STATED THAT THE PRODUCT HAD A LABELING-PACKAGING ERROR ¿ 35F VS 32F. ACCORDING TO THE REPORT, THIS POSED A POTENTIAL MODERATE TO HIGH RISK OF INEFFECTIVE VENTILATION, AIRWAY TRAUMA, AND PRODUCT EXCHANGE IN A STERILE FIELD. THE PRODUCT'S STATUS AT THE TIME OF THE EVENT WAS PRIOR TO BEING USED, AND ITS USE WAS INTERCEPTED AT THE SURGERY ROOM. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23545211 ↗
• MalfunctionNov 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING TRACHEAL INTUBATION AN AIR LEAK WAS DETECTED WHEN THE CUFF WAS INFLATED FOR FIXATION, AND THE TUBE WAS IMMEDIATELY REPLACED WITH A DOUBLE-LUMEN CUFFED TUBE, WITHOUT AFFECTING THE PATIENT'S TREATMENT OUTCOME. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465282 ↗
• MalfunctionOct 23, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514560 ↗
• MalfunctionOct 9, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE TUBE, AND IT WAS LEAKING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408905 ↗
• MalfunctionMar 28, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT "NO CONNECTOR IN THE PACKAGE." THIS OCCURRED UPON REMOVAL FROM PACKAGE, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995646 ↗
• MalfunctionJan 17, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THE CONNECTORS WERE NOT INCLUDED IN THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527571 ↗
• MalfunctionSep 18, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, A BLUE FOREIGN SUBSTANCE WAS FOUND ON THE PRODUCT. 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 17769696 ↗
• MalfunctionAug 31, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT BEFORE USE IT WAS FOUND THAT THERE WAS AN AIR LEAKAGE AND THEN REPLACED IT WITH ANOTHER CONSUMABLE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17661875 ↗
• InjuryAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT AFTER INTUBATION IT WAS FOUND THAT THE AIR BAG WAS RUPTURED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 17656618 ↗
• MalfunctionApr 6, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED AIR WAS UNABLE TO BE PUT IN THE BLUE CUFF. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16695325 ↗
• MalfunctionJan 11, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT ALL THE PRODUCTS STACKED ON THE TOP OF THE PALLET ARE PACKED UP WITHOUT SHIPPING CARTONS. THE CUSTOMER STATED THAT IT CAN'T BE RETURNED TO THE INVESTIGATION LAB. CONSIDERING ALL MEDICAL PRODUCTS WERE ALL HELD AT CUSTOMS INSPECTION SITE, THESE PRODUCTS ARE IMPOSSIBLE FOR RETURN INVESTIGATION. WE WOULD MAKE DESTRUCTION ON ALL COMPLAINTS PRODUCTS IN THE END OF YEAR AT THE BONDED WAREHOUSE OF SHANGHAI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141604 ↗
• MalfunctionJan 11, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT ALL THE PRODUCTS STACKED ON THE TOP OF THE PALLET ARE PACKED UP WITHOUT SHIPPING CARTONS. THE CUSTOMER STATED THAT CAN'T BE RETURNED TO THE INVESTIGATION LAB. CONSIDERING ALL MEDICAL PRODUCTS WERE ALL HOLD AT CUSTOMS INSPECTION SITE; THESE PRODUCTS ARE IMPOSSIBLE FOR RETURN INVESTIGATION. WE WOULD MAKE DESTRUCTION ON ALL COMPLAINT'S PRODUCTS IN THE END OF YEAR AT THE BONDED WAREHOUSE OF SHANGHAI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141601 ↗
• MalfunctionJan 11, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT ALL THE PRODUCTS STACKED ON THE TOP OF THE PALLET ARE PACKED UP WITHOUT SHIPPING CARTONS. THE CUSTOMER STATED THAT THE DEVICE CAN'T BE RETURNED TO THE INVESTIGATION LAB. CONSIDERING ALL MEDICAL PRODUCTS WERE ALL HOLD AT CUSTOMS INSPECTION SITE; THESE PRODUCTS ARE IMPOSSIBLE FOR RETURN INVESTIGATION. WE WOULD MAKE DESTRUCTION ON ALL COMPLAINT'S PRODUCTS IN THE END OF YEAR AT THE BONDED WAREHOUSE OF SHANGHAI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141584 ↗
• MalfunctionJan 11, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT ALL THE PRODUCTS STACKED ON THE TOP OF THE PALLET ARE PACKED UP WITHOUT SHIPPING CARTONS. THE CUSTOMER STATED THAT IT CAN'T BE RETURNED TO THE INVESTIGATION LAB. CONSIDERING ALL MEDICAL PRODUCTS WERE ALL HOLD AT CUSTOMS INSPECTION SITE THESE PRODUCTS ARE IMPOSSIBLE FOR RETURN INVESTIGATION. WE WOULD MAKE DESTRUCTION ON ALL COMPLAINT'S PRODUCTS IN THE END OF YEAR AT THE BONDED WAREHOUSE OF SHANGHAI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141582 ↗
• MalfunctionJan 11, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT ALL THE PRODUCTS STACKED ON THE TOP OF THE PALLET ARE PACKED UP WITHOUT SHIPPING CARTONS. THE CUSTOMER STATED THAT CAN'T BE RETURNED TO THE INVESTIGATION LAB. CONSIDERING ALL MEDICAL PRODUCTS WERE ALL HOLD AT CUSTOMS INSPECTION SITE; THESE PRODUCTS ARE IMPOSSIBLE FOR RETURN INVESTIGATION. WE WOULD MAKE DESTRUCTION ON ALL COMPLAINT'S PRODUCTS IN THE END OF YEAR AT THE BONDED WAREHOUSE OF SHANGHAI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16141573 ↗
• MalfunctionNov 11, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE CURVATURE OF 35 FR LEFT DLT NOT CONFORMING TO STANDARD. IN FINAL POSITION OF DLT BRONCHIAL CURRENT POINTING DOWNWARD INSTEAD OF TO THE LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15778539 ↗
• MalfunctionNov 10, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE CURVATURE OF 35 FR LEFT DLT NOT CONFORMING TO STANDARD. IN FINAL POSITION OF DLT BRONCHIAL CURRENT POINTING DOWNWARD INSTEAD OF TO THE LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775155 ↗
• MalfunctionOct 21, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT, IMMEDIATELY AFTER OPENING THE PACKAGE, WITH THE EXCEPTION OF THE ENDOTRACHEAL TUBE, ITS COMPONENTS OR ACCESSORIES WERE MISSING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15651737 ↗
• MalfunctionSep 4, 2022Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE BRONCHIAL CUFF (THE WHITE CUFF) DEFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353807 ↗
• MalfunctionJul 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE TRACHEAL CUFF WAS UNABLE TO BE INFLATED. NO PATIENT INJURY OR ADVERSE AFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15052433 ↗
• MalfunctionJun 23, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE BLUE CUFF WOULD NOT BE INFLATED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14787085 ↗
• MalfunctionFeb 23, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587917 ↗
• MalfunctionFeb 9, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE TUBE'S LUMEN WAS CURVED IN AN S SHAPE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502007 ↗
• MalfunctionJan 27, 2022Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367028 ↗
• MalfunctionJan 7, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195367 ↗