Lifeshield 1273465Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD Primary Y-Type Blood Set, Non-Vented, 170 Micron Filter, Prepierced Y-Site, 79 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 10887787007142), received between May 20, 2025 and May 20, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Rupture” (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.
Reports received per month
Most reported problems
Device problems
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2025Material Rupture; Material Rupture
THE EVENT INVOLVED A PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, SECURE LOCK, 80 INCH. THE PROBLEM WAS: THE DRIP CHAMBER, WHICH CONTAINS THE FILTER FOR THE TRANSFUSION TUBING, BURST WHEN THE NURSE WAS HANDLING IT NEAR THE END OF THE BLOOD TRANSFUSION, AND THE BLOOD "EXPLODED" ON THE NURSE. THE NURSE WAS USING THE TUBE FOR A BLOOD TRANSFUSION. SHE WAS NEAR THE END AND WANTED TO GET ALL THE BLOOD OUT OF THE BAG IN THE ROOM, SO SHE GAVE IT A LITTLE PRESSURE, AND IT BURST. BLOOD SPILLED EVERYWHERE. NO DEFECTS WERE NOTICED BEFORE USING THE PRODUCT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22055056 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.