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 ↗
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- Medline Industries, Inc. PHS972096014BMedline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)3 recalls0 reports
- Medline Industries, Inc. DYNJ0185290GMedline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)3 recalls0 reports
- Medline Industries, Inc. DYNJ905503GMedline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)2 recalls0 reports
- Medline Industries, Inc. DYNJAA262AMedline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)2 recalls0 reports
- Medline Industries, Inc. DYNJ905567AMedline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)2 recalls0 reports
- MEDLINE INDUSTRIES, INC. DYNJ86657AMedline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)2 recalls0 reports
- Medline Industries, Inc. DYKMBNDL199AMedline Industries, Inc. · Circuit, breathing (w connector, adaptor, y piece)2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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