Portex 100/399/216Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00351688068135), received between Aug 31, 2022 and Dec 9, 2022 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Disconnection” (5 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
- Disconnection5
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS AN ADHERENCE FAILURE ON THE PRODUCT. THE EPIDURAL NEEDS TO BE REAPPLIED FOR AT LEAST 5 MATERNITY PATIENTS WHO RECEIVED THIS LOT, FAILURE DID NOT OCCUR WITH OTHER LOT NUMBERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15955494 ↗MalfunctionDec 9, 2022Disconnection; Disconnection
ADDITIONAL INFORMATION WAS RECEIVED ON 22-DEC-2022: A SECOND EPIDURAL HAD BEEN GIVEN TO ONE IN TWO PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15955126 ↗MalfunctionDec 9, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS AN ADHERENCE FAILURE ON THE PRODUCT. THE EPIDURAL NEEDS TO BE REAPPLIED FOR AT LEAST 5 MATERNITY PATIENTS WHO RECEIVED THIS LOT, FAILURE DID NOT OCCUR WITH OTHER LOT NUMBERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15955105 ↗MalfunctionDec 9, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS AN ADHERENCE FAILURE ON THE PRODUCT. THE EPIDURAL NEEDS TO BE REAPPLIED FOR AT LEAST 5 MATERNITY PATIENTS WHO RECEIVED THIS LOT, FAILURE DID NOT OCCUR WITH OTHER LOT NUMBERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15954902 ↗MalfunctionDec 9, 2022Disconnection; Disconnection
IT WAS REPORTED THAT THERE WAS AN ADHERENCE FAILURE ON THE PRODUCT. THE EPIDURAL NEEDS TO BE REAPPLIED FOR AT LEAST 5 MATERNITY PATIENTS WHO RECEIVED THIS LOT, FAILURE DID NOT OCCUR WITH OTHER LOT NUMBERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15954746 ↗MalfunctionAug 31, 2022Break; Break
IT WAS REPORTED THAT DURING THE PLACEMENT OF THE EPIDURAL, WHEN THE ANESTHETIST WANTED TO CLOSE THE MOBILE PART OF THE SAMPLE, THIS SAMPLE WAS BROKEN. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15329853 ↗
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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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