Lifeshield 1267828Recalls & reported problems
ICU Medical, Inc. · LIFESHIELD, Extension Set - 32 Inch, 2 CLAVE Y-Sites, Secure Lock · 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 10887787006107), received between Nov 13, 2023 and Nov 13, 2023 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
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.
MalfunctionNov 13, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE EVENT INVOLVED AN EXTENSION SET, 32 INCH, 2 CLAVE(TM) Y-SITES, SECURE LOCK IN WHICH THE CUSTOMER REPORTED THAT THE BLOOD BACKED UP INTO THE EXTENSION SET AND LEAKED OUT ONE OF THE Y SITE CLAVES. THE DEVICE WAS CHANGED OUT/REPLACED WITH NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS NO BLOOD LOSS, NO UNPROTECTED CHEMO EXPOSURE AND THERE WAS NO DELAY IN CRITICAL THERAPY. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO ADVERSE OUTCOME AS A CONSEQUENCE OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18119501 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.