Portex C45031682D-NLRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019315089381), received between Feb 13, 2025 and Apr 16, 2026 — classified as 8 malfunctions.

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

• MalfunctionApr 16, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A HOLE IN THE CIRCUIT. THE DEVICE WAS OPERATED UNDER ANESTHESIA. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897000 ↗
• MalfunctionOct 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT LEAKAGE/HOLES WERE FOUND IN THE TUBING INTRAOPERATION WHILE THE ANESTHESIA CIRCUIT WAS CONNECTED TO AN INTUBATED PATIENT. THE CIRCUIT WAS REPLACED TO ADDRESS THIS ISSUE AND A PREGNANT TECHNICIAN IN THE OPERATING ROOM WAS EXPOSED TO ANESTHESIA GASSES. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23327734 ↗
• MalfunctionMay 12, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THE ANESTHESIA REPEATEDLY FAILED THE LEAK CHECK. A PIN SIZED HOLE WAS FOUND IN THE MACHINE CIRCUIT WHICH MIGHT NEGATIVELY IMPACTED THE PATIENT AND IMPAIRED VENTILATION. THIS HAPPENED AGAIN AFTER EXCHANGE FOR A NEW CIRCUIT. THE EVENT WAS FOUND BEFORE STARTING THE THERAPY. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002881 ↗
• MalfunctionApr 1, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THE ANESTHESIA REPEATEDLY FAILED THE LEAK CHECK. A PIN SIZED HOLE WAS FOUND IN THE MACHINE CIRCUIT WHICH MIGHT NEGATIVELY IMPACTED THE PATIENT AND IMPAIRED VENTILATION. THIS HAPPENED AGAIN AFTER EXCHANGE FOR A NEW CIRCUIT. THE EVENT WAS FOUND BEFORE STARTING THE THERAPY. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741397 ↗
• MalfunctionApr 1, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THE ANESTHESIA REPEATEDLY FAILED THE LEAK CHECK. A PIN SIZED HOLE WAS FOUND IN THE MACHINE CIRCUIT WHICH MIGHT NEGATIVELY IMPACTED THE PATIENT AND IMPAIRED VENTILATION. THIS HAPPENED AGAIN AFTER EXCHANGE FOR A NEW CIRCUIT. THE EVENT WAS FOUND BEFORE STARTING THE THERAPY. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741227 ↗
• MalfunctionMar 13, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT THREE ANESTHESIA CIRCUITS DID NOT PASS THE DAILY LEAKAGE TESTS BECAUSE THE TUBING HAD HOLES IN THEM. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596619 ↗
• MalfunctionFeb 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCTS HAVE BEEN LEAKING. DURING THE LEAK TEST, THE PRODUCTS FAILED WITH GREATER THAN 450ML OF LOSS ON MULTIPLE ANESTHESIA MACHINES. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379743 ↗
• MalfunctionFeb 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCTS HAVE BEEN LEAKING. DURING THE LEAK TEST, THE PRODUCTS FAILED WITH GREATER THAN 450ML OF LOSS ON MULTIPLE ANESTHESIA MACHINES. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21379708 ↗