Portex 100/591/080Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019315048326), received between Apr 2, 2019 and Apr 3, 2019 — classified as 4 injuries.
The most frequently reported specific device problem is “Leak/Splash” (4 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
Device problems
- Leak/Splash4
Patient problems
- Low Oxygen Saturation4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 3, 2019Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY WAS TESTED PRIOR TO USE AND NO LEAKAGE NOTED. HOWEVER, UPON USE, THE PATIENT'S VITAL SIGNS BEGAN DROPPING, OXYGEN SATURATION WAS DECREASING. DEVICE WAS REMOVED AND REPLACEMENT TUBE WAS USED. A LEAK IN THE BALLOON WAS NOTED.
Patient problems: Low Oxygen Saturation
MAUDE report 8480104 ↗InjuryApr 3, 2019Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY WAS TESTED PRIOR TO USE AND NO LEAKAGE NOTED. HOWEVER, UPON USE, THE PATIENT'S VITAL SIGNS BEGAN DROPPING, OXYGEN SATURATION WAS DECREASING. DEVICE WAS REMOVED AND REPLACEMENT TUBE WAS USED. A LEAK IN THE BALLOON WAS NOTED.
Patient problems: Low Oxygen Saturation
MAUDE report 8480102 ↗InjuryApr 3, 2019Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY WAS TESTED PRIOR TO USE AND NO LEAKAGE NOTED. HOWEVER, UPON USE, THE PATIENT'S VITAL SIGNS BEGAN DROPPING, OXYGEN SATURATION WAS DECREASING. DEVICE WAS REMOVED AND REPLACEMENT TUBE WAS USED. A LEAK IN THE BALLOON WAS NOTED.
Patient problems: Low Oxygen Saturation
MAUDE report 8480101 ↗InjuryApr 2, 2019Leak/Splash; Leak/Splash
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY WAS TESTED PRIOR TO USE AND NO LEAKAGE NOTED. HOWEVER, UPON USE, THE PATIENT'S VITAL SIGNS BEGAN DROPPING, OXYGEN SATURATION WAS DECREASING. DEVICE WAS REMOVED AND REPLACEMENT TUBE WAS USED. A LEAK IN THE BALLOON WAS NOTED.
Patient problems: Low Oxygen Saturation
MAUDE report 8474835 ↗
Other Tube tracheostomy and tube cuff devices
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- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 7CN80RCovidien LP · Tube tracheostomy and tube cuff2 recalls148 reports
- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 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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