Lifeshield 1264828Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD, Extension Set - 32 Inch, 2 Prepierced Y-Sites, Secure Lock · Class 2
All models of Lifeshield (34)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887787005469), received between Sep 18, 2018 and Jul 30, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (2 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. 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
- Material Fragmentation2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Material Separation; Material Separation
THE EVENT INVOLVED AN EXTENSION SET, 32 INCH, 2 PREPIERCED Y-SITES, SECURE LOCK WHERE THE CUSTOMER REPORTED THAT 'ANY PULLING AT ALL' CAUSES THE EXTENSION SET TO COME APART AT THE Y SITE. THE EVENT DATE WAS 23-JUN-2025. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO ADVERSE EVENT/PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22667843 ↗MalfunctionSep 18, 2018Material Fragmentation; Material Fragmentation
THE EVENT OCCURRED ON AN UNKNOWN DATE IN (B)(6) 2018 AND INVOLVED A CUSTOMER ALLEGATION STATING THAT UPON OPENING OF THE ORIGINAL PACKAGING, A BIT OF PLASTIC DEBRIS WAS OBSERVED TO BE IN THE TUBING. THERE WAS NO MEDICATION BEING USED WITH THE PRODUCT. NO ADDITIONAL INFORMATION WAS REPORTED. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7886728 ↗MalfunctionSep 18, 2018Material Fragmentation; Material Fragmentation
THE EVENT INVOLVED A CUSTOMER ALLEGATION STATING THAT UPON OPENING OF THE ORIGINAL PACKAGING, A BIT OF PLASTIC DEBRIS WAS OBSERVED TO BE IN THE TUBING. THERE WAS NO MEDICATION BEING USED WITH THE PRODUCT. NO ADDITIONAL INFORMATION WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7886606 ↗
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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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