Portex 197-37RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315058561), received between Aug 23, 2024 and Oct 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER UNPACKING THE NEW DOUBLE-LUMEN ENDOBRONCHIAL TUBE, THE AIR BAG WAS FOUND TO BE LEAKING AND COULD NOT BE USED NORMALLY. THEY IMMEDIATELY REPLACED WITH ANOTHER PRODUCT FOR TREATMENT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431969 ↗
• MalfunctionAug 23, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AFTER UNPACKING THE NEW DOUBLE LUMEN ENDO BRONCHIAL TUBE AIRBAG WAS FOUND TO BE LEAKING. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057905 ↗