Portex 450952-NLRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019315075834), received between Oct 29, 2020 and Oct 29, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23413782 ↗
• MalfunctionJun 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT LEAKAGE WAS CONFIRMED FROM THE LEAKAGE, SO USAGE OF THE PRODUCT WAS CEASED. PER REPORTER, THE ISSUE WAS DISCOVERED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328272 ↗
• MalfunctionJan 18, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING TESTING, THE ANESTHESIA MACHINE LEAK CHECK DID NOT PASS. A LEAK WAS DETECTED. NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18537239 ↗
• MalfunctionSep 19, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CONNECTOR GOT DETACHED FROM THE BREATHING BAG. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446809 ↗
• MalfunctionSep 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE CORRUGATED TUBE WAS FOUND TO BE DISCONNECTED FROM THE PATIENT-SIDE Y-SITE CONNECTOR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437096 ↗
• MalfunctionSep 13, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PRE-USE CHECK THE CUSTOMER FOUND A PINHOLE IN THE ANESTHESIA CIRCUIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410938 ↗
• MalfunctionApr 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE BREATHING FILTER GOT EASILY DETACHED FROM THE BREATHING CIRCUIT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102947 ↗
• MalfunctionOct 29, 2020Gas/Air Leak; Gas/Air Leak

  INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10755147 ↗