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Portex CE123Recalls & reported problems

Icu Medical, Inc. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315012471), received between Jul 13, 2017 and Jul 13, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Too Rigid or Stiff1

Patient problems

  • Blood Loss1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 13, 2017Material Too Rigid or Stiff; Material Too Rigid or Stiff

    IT WAS REPORTED THAT A WALLACE¿ SURE VIEW® EMBRYO REPLACEMENT CATHETER WAS "STIFFER THAN USUAL". A DOCTOR OBSERVED THAT THE CATHETER APPEARED TO CAUSE TRAUMA AND A BLEEDING CONDITION DURING AN IN VITRO FERTILIZATION PROCEDURE. NO PERMANENT INJURY WAS REPORTED.

    Patient problems: Blood Loss

    MAUDE report 6711851 ↗

Other CATHETER, ASSISTED REPRODUCTION devices

All CATHETER, ASSISTED REPRODUCTION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.