Lifeshield 1267228Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD, Primary Set, Prepierced Y-Site, Secure Lock, 80 Inch · Class 2
All models of Lifeshield (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887787006022), received between May 7, 2025 and May 26, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2026Fluid/Blood Leak
A PRIMARY SET, PREPIERCED Y-SITE, SECURE LOCK, 80 INCH REPORTEDLY LEAKED FOUR DROPS OF CHEMOTHERAPY (DOXORUBICIN) FROM THE Y-SITE LESS THAN 10 MINUTES INTO A 30-MINUTE INFUSION. THE FOUR DROPS LEAKED ONTO THE FLOOR. THE PORT WAS NOT PIERCED AT THE TIME, THE PRODUCT WAS USED IN CONJUNCTION WITH CLOSED SYSTEM TRANSFER DEVICES (CSTDS). THE STAFF CLEANED THE SPILLS WHICH CONSISTED OF FOUR DROPLETS ON THE FLOOR. THIS WAS USED ON A VETERINARY PATIENT. THERE WAS NO INJURY TO PATIENT OR HEALTH PROFESSIONAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25279297 ↗MalfunctionMay 7, 2025Separation Problem; Separation Problem
THE EVENT INVOLVED PRIMARY SET, PREPIERCED Y-SITE, SECURE LOCK, 80 INCH WHERE THE CUSTOMER REPORTED 5 INSTANCES (UNSPECIFIED DATES) THAT THE TUBING Y SITES KEEPS COMING OUT WHEN BEING USED. THERE WAS PATIENT INVOLVEMENT, BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21979508 ↗
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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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