Skip to content

Lifeshield 1421828Recalls & reported problems

ICU Medical, Inc. · LIFESHIELD, Primary Y-Type Blood Set, 200 Micron Filter, CLAVE Y-Site, Secure Lock, 80 Inch · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887787006459), received between Jan 13, 2020 and Jan 13, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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

  • Infusion or Flow Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 13, 2020Infusion or Flow Problem; Infusion or Flow Problem

    THE EVENT INVOLVED A BLOOD SET THAT WAS REPORTED TO BE SEEN SUCKING AIR INTO THE SET UPON ADMINISTRATION OF BLOOD PRODUCTS TO A PATIENT. THERE WAS PATIENT INVOLVEMENT, NO ADVERSE EVENT, AND NO ONE WAS HARMED AS A RESULT OF THE REPORTED EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9582627 ↗

Other Set, administration, intravascular devices

All Set, administration, intravascular devices →

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