Jelco 402515Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00351688070893), received between Aug 30, 2022 and Sep 1, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Obstruction of Flow2
- Leak/Splash1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 1, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547654 ↗MalfunctionFeb 20, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT PRODUCT DID NOT WORK CORRECTLY, AND THE MEDICATION WAS SPRAYED OUT UNEXPECTEDLY. THERE WERE 2 BOXES AFFECTED. THERE WAS UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21428590 ↗MalfunctionAug 31, 2022Fluid/Blood Leak; Material Twisted/Bent; Fluid/Blood Leak; Material Twisted/Bent
IT WAS REPORTED THAT WHILE TWISTING THE NEEDLE ONTO THE SYRINGE THE NECK PART OF THE DEVICE CRACKS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15326341 ↗MalfunctionAug 30, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT WHILE INJECTING THE PATIENT WITH DEPO, THE NEEDLE BECAME CLOGGED HALF WAY THROUGH. A DIFFERENT NEEDLE OF THE SAME LOT WAS TRIED AND IT ALSO CLOGGED. THE USER DID A TEST WITH WATER AND IT CLOGGED TOO. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15320272 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.