Portex 100/110/080Recalls & 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
- 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 15019315050800), received between Jan 5, 2021 and May 26, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Most reported problems
Device problems
- Leak/Splash3
- Gas/Air Leak1
- Material Split, Cut or Torn1
- Mechanical Problem1
Patient problems
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2021Gas/Air Leak; Gas/Air Leak
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS LEAKING AIR FROM THE PILOT BALLOON. THERE WAS NO PATIENT INJURY AND NO REPORTED ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11888609 ↗MalfunctionApr 10, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER SUSPECTED AIR WAS LEAKING FROM THE CUFF OF A SMITHS MEDICAL TRACH TUBE. NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 11646640 ↗MalfunctionMar 2, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES MALFUNCTIONED. REPORTED THE PILOT BALLOON DETACHED DURING INTUBATION ,PHYSICIAN MANAGED TO INFLATE CUFF BY APPLYING ADHESIVE TAPE. UNABLE TO DEFLATE CUFF DURING EXTUBATION. NO COMPLICATIONS TO PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11402280 ↗MalfunctionJan 22, 2021Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem
INFORMATION WAS RECEIVED THAT PRE-TESTING OF THIS SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBES, LEAKAGE OF AIR FROM THE CUFF WAS DETECTED. NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11217635 ↗MalfunctionJan 5, 2021Leak/Splash; Leak/Splash
DURING A PRE-USE CHECK, THE CUSTOMER NOTICED AIR WAS LEAKING FROM THE CUFF. NO PATIENT INJURY.
Patient problems: No Patient Involvement
MAUDE report 11116646 ↗
Other Tube, tracheal (w/wo connector) devices
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- RUSCH IPN041476Teleflex Incorporated · Tube, tracheal (w/wo connector)10 recalls0 reports
- Shiley 18775Covidien LP · Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Covidien LP · Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 18880Covidien LP · Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 18780Covidien LP · Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770SCovidien LP · Tube, tracheal (w/wo connector)273 reports
- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 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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