Portex 008201Recalls & reported problems
Icu Medical, Inc. · Class 2
- 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 10351688426352), received between Aug 4, 2021 and May 2, 2023 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Product Quality Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 2, 2023Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THERE WERE INK STAINS ON THE SURFACE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16857620 ↗MalfunctionFeb 15, 2022Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THERE ARE INK STAINS ON THE SURFACE OF THE NANOMETER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13537500 ↗MalfunctionFeb 15, 2022Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THERE WERE INK STAINS ON THE SURFACE OF MANOMETER. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13537051 ↗MalfunctionAug 4, 2021Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THERE WERE INK STAINS ON THE DEVICES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12277282 ↗MalfunctionAug 4, 2021Product Quality Problem; Product Quality Problem
IT WAS REPORTED THAT THERE WERE INK STAINS ON THE SURFACE OF THE DEVICES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12277180 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.