Portex C45101796D-NLRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517069990), received between Feb 17, 2017 and Feb 17, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
Device problems
- Fracture1
- Inflation Problem1
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2017Fracture; Fracture
IT WAS REPORTED THAT THE DURING USE OF A DISPOSABLE PORTEX® ANESTHESIA BREATHING CIRCUIT, THE CO2 PORT BROKE WHILE TURNING THE HEAT AND MOISTURE EXCHANGER (HME). ACCORDING TO THE REPORTER, THE EVENT OCCURRED IN THE OPERATING ROOM WHILE THE DEVICE WAS CONNECTED TO THE PATIENT. THE HME WAS REPLACED. NO PATIENT INJURY OCCURRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6341343 ↗InjuryFeb 17, 2017Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
IT WAS REPORTED THAT THE PORTEX® CLEAR PVC, ORAL/NASAL, PROFILE SOFT SEAL® CUFF TRACHEAL TUBES WERE "FAILING" DURING SURGERY. ACCORDING TO THE REPORTER, THE TRACHEAL TUBES WOULD NOT HOLD INFLATION AND WOULD LEAK. THE PATIENTS WERE RE-INTUBATED DURING SURGERY. NO ADVERSE EVENT WAS REPORTED. RELATED MFR #'S: 3012307300-2017-00480, 3012307300-2017-00481.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6341341 ↗
Other Filter, bacterial, breathing-circuit devices
- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall570 reports
- VOCSN V+Pro Emergency, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit558 reports
- VOCSN V+O+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit3 recalls366 reports
- VOCSN V+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit2 recalls2 deaths325 reports
- VOCSN V+C+S+N+Pro, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit185 reports
- GIBECK IPN043751Teleflex Incorporated · Filter, bacterial, breathing-circuit2 recalls7 reports
- VOCSN VOCSN, EnglishVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 death96 reports
- VOCSN V+C+Pro, JapaneseVentec Life Systems, Inc. · Filter, Bacterial, Breathing-Circuit1 recall33 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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