Portex 55-6060Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10788942560604), received between Sep 19, 2022 and Apr 27, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Failure to Zero1
- Incorrect Measurement1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Operating System Becomes Nonfunctional1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Zero; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Zero
IT WAS REPORTED THAT THE GAUGE DOES NOT READ CORRECTLY AND IS NOT SET FOR ZERO (0). PATIENT INVOLVEMENT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 16827964 ↗MalfunctionSep 19, 2022Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional
IT WAS REPORTED THAT THE FUNCTIONAL TESTE FAILED. AFTER TESTING WITH POSITIVE AND NEGATIVE PRESSURE USING A SMALL SYRINGE, THE GAUGE POINTER CANNOT RETURN TO ZERO AND STOPS AT JUST OUTSIDE THE EDGE OF THE BLACK SQUARE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15445578 ↗MalfunctionSep 19, 2022Defective Component; Defective Component
IT WAS REPORTED THAT THE RED INDICATOR NEEDLE DOES NOT MOVE WITH THE BLACK NEEDLE WHEN UNDER PRESSURE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15444999 ↗
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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