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Portex C49291785D-NLRecalls & reported problems

Icu Medical, Inc. · Class 1

All models of Portex (409)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517050530), received between Jun 19, 2017 and Jun 28, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (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 18, 2026.

Most reported problems

Device problems

  • Crack3
  • Leak/Splash3
  • Connection Problem2
  • Disconnection1

Patient problems

  • No Consequences Or Impact To Patient5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 28, 2017Crack; Crack

    IT WAS REPORTED THAT THE WYE ON A PORTEX® CUSTOM ANESTHESIA BREATHING CIRCUIT WAS CRACKED AFTER FIVE MINUTES IN USE. NO INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6673498 ↗
  • MalfunctionJun 19, 2017Disconnection; Disconnection

    IT WAS REPORTED THAT THE HOSPITAL EXPERIENCED A "DISCONNECT" FROM "LOOSER FITTING" DURING USE OF A PORTEX® ANESTHESIA BREATHING CIRCUIT. NO INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6651211 ↗
  • MalfunctionJun 19, 2017Leak/Splash; Leak/Splash

    IT WAS REPORTED THAT A LEAK WAS EXPERIENCED AROUND THE SWIVEL CONNECTOR AT THE GAS SAMPLING LINE CONNECTOR OF A PORTEX® ANESTHESIA BREATHING CIRCUIT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6651206 ↗
  • MalfunctionJun 19, 2017Crack; Leak/Splash; Connection Problem; Crack; Leak/Splash; Connection Problem

    IT WAS REPORTED THAT THE ELBOW CONNECTION OF A PORTEX® ANESTHESIA BREATHING CIRCUIT CRACKED AND CAUSE A "LARGE LEAK" INTRA-OPERATIVELY. THE EVENT OCCURRED IN THE HOSPITAL AFTER ONE DAY IN USE. THE ORIGINAL INTENDED PROCEDURE WAS GENERAL ANESTHESIA. NO INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6651200 ↗
  • MalfunctionJun 19, 2017Crack; Leak/Splash; Connection Problem; Crack; Leak/Splash; Connection Problem

    IT WAS REPORTED THAT THE ELBOW CONNECTION OF A PORTEX® ANESTHESIA BREATHING CIRCUIT CRACKED AND CAUSE A "LARGE LEAK" INTRA-OPERATIVELY. THE EVENT OCCURRED IN THE HOSPITAL AFTER ONE DAY IN USE. THE ORIGINAL INTENDED PROCEDURE WAS GENERAL ANESTHESIA. NO INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6651198 ↗

Other Circuit, breathing (w connector, adaptor, y piece) devices

All Circuit, breathing (w connector, adaptor, y piece) devices →

Sources and updates

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