Portex 198-37LRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 15019315058622), received between Jun 16, 2017 and Aug 13, 2026 — classified as 3 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50235313 ↗
• MalfunctionNov 20, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE AIR WAS LEAKING FROM THE CUFF. THE EVENT OCCURRED DURING PRIMING AT FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609675 ↗
• MalfunctionJan 15, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "WHEN WE PERFORMED A CUFF CHECK, WE FOUND THAT THE CUFF DID NOT INFLATE. THE EVENT OCCURRED BEFORE PATIENT USE/DURING PRIMING AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160415 ↗
• MalfunctionDec 5, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "IN THE CUFF CHECK BEFORE THE START OF THE CASE, THE PILOT BALLOON OF THE WHITE CUFF INFLATED, BUT THE WHITE CUFF ITSELF HARDLY INFLATED." THE EVENT OCCURRED DURING PRIMING AT THE FACILITY, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20859693 ↗
• MalfunctionSep 9, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20172528 ↗
• MalfunctionAug 12, 2024Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT BEFORE USE WITH THE DEVICE AIR ENTERED THE WHITE CUFF BUT DID NOT COME OUT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967682 ↗
• MalfunctionMar 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE WHITE CUFF INFLATED WITHOUT ANY PROBLEM, BUT THE WHITE CUFF PILOT BALLOON WOULD NOT INFLATE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18902497 ↗
• MalfunctionMar 8, 2024Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS OPENED AND CHECKED. THE TRACHEAL CUFF OF THE DLT WAS FOUND TO BE DEFECTIVE, LEAKAGE WAS FOUND THERE. THE PATIENT WAS PREPARED FOR SURGERY BUT BEFORE USING THE TRACHEAL CUFF OF THE DLT WAS FOUND TO BE DEFECTIVE UPON OPENING. ANOTHER DLT 37 FR (LEFT) SIDE WAS OPENED, CHECKED AND USED FOR THE PATIENT. THE PRODUCTS ARE FROM SAME LOT. THE EVENT OCCURRED IN THE PREMISES OF (B)(6) HOSPITAL I.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867672 ↗
• MalfunctionDec 20, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A CUFF PRESSURE CHECK BEFORE USE THERE WAS LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365955 ↗
• MalfunctionNov 21, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT UPON OPENING, THERE WAS A "LACK OF ACCESSORIES". CONNECTOR PART WAS NOT INCLUDED. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187700 ↗
• MalfunctionAug 1, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AFTER INFLATING THE CUFF, THE CLIENT ATTEMPTED TO DEFLATE IN ORDER TO EXTUBATE THE PATIENT BEFORE AWAKENING FROM ANESTHESIA. HOWEVER, THE AIR IN THE CUFF DID NOT ESCAPE. THE CUSTOMER SUSPECTED A BLOCKED INFLATION LINE. PATIENT INJURY OR ADVERSE EFFECTS HAVE NOT BEEN REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17435217 ↗
• MalfunctionJun 26, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED NO Y-CONNECTOR WAS CAME WITH THE PRODUCT SET. 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 17203427 ↗
• MalfunctionMay 3, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED A BLACK FOREIGN SUBSTANCE WAS ADHERED TO THE PRODUCT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860619 ↗
• MalfunctionMay 2, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE END CAPS (A BLUE ONE AND A TRANSPARENT ONE) WERE ATTACHED TO THE WRONG TUBES RESPECTIVELY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852505 ↗
• MalfunctionMay 1, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE TIP OF THE TUBE WAS DEFORMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16844084 ↗
• MalfunctionApr 28, 2023Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, A TEAR IN THE CUFF WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16832281 ↗
• MalfunctionApr 27, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE WHITE CUFF WAS UNABLE TO BE DEFLATED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION: BODY FLUID WAS ATTACHED TO THE RETURNED PRODUCT THEREFORE THE EVENT LIKELY TO HAVE OCCURRED DURING USE. NO PATIENT INJURY OCCURRED AND THE REPORTS ISSUE WAS RESOLVED BY REPLACING THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828448 ↗
• MalfunctionNov 4, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN OPENING THE BOX A MISSING Y-CONNECTOR WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15736051 ↗
• MalfunctionNov 4, 2022Material Perforation; Material Perforation

  IT WAS REPORTED THE TEST OF THE TWO BALLONET WAS PERFORMED BEFORE USE. AFTER THE OTI (OROTRACHEAL INTUBATION) ON THE PATIENT, AND A RESISTANCE TEST WAS PERFORMED, THE BLUE CUFF OF THE DISTAL ROUTE SHOWED LITTLE RESISTANCE, WITH PERFORATION OF THE CUFF BEING FOUND. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729797 ↗
• MalfunctionSep 7, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED SOMETHING WAS WRONG WITH THE CUFF. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369264 ↗
• MalfunctionSep 6, 2022Break; Break

  IT WAS REPORTED THAT THE WHITE CUFF WAS FOUND TO BE RUPTURED BEFORE INTUBATION AND COULD NOT BE USED NORMALLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362733 ↗
• MalfunctionSep 4, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT IMMEDIATELY AFTER OPENING THE PACKAGE OF A PRODUCT THE INCORRECT SIZE OF THE PRODUCT WAS IN THE PACKAGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353889 ↗
• MalfunctionMar 4, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE BOX IS LABELED 37F BUT IN THE BOX THE PHYSICAL UNIT IS 35F. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13667253 ↗
• MalfunctionOct 25, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12693871 ↗
• MalfunctionJun 17, 2021Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH TUBE FELT WRONG AND SO IT WAS NOTED THAT THE TUBE WAS DEFORMED. THERE WERE NO REPORTED ADVERSE EVENTS AND NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12018202 ↗