Jelco 982312Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20351688060003), received between Jul 12, 2023 and Aug 28, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Complete Blockage” (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
- Complete Blockage2
- Fail-Safe Did Not Operate2
- Obstruction of Flow2
- Fail-Safe Problem1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Insufficient Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Obstruction of Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503288 ↗MalfunctionFeb 12, 2026Complete Blockage
IT WAS REPORTED THAT THE TUBING WAS CRINKLED, AND THE BLOOD DID NOT FLOW. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327278 ↗MalfunctionFeb 12, 2026Complete Blockage
IT WAS REPORTED THAT THE TUBING WAS CRINKLED, AND THE BLOOD DID NOT FLOW. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24327157 ↗MalfunctionMay 8, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE NEEDLE'S PROTECTIVE COVER HAS FALLEN OFF PRIOR TO THE PACKAGE BEING OPENED. THIS ISSUE ALREADY HAPPENED TWICE, WHEREAS ON ONE INSTANCE, THE PHLEBOTOMIST STUCK HERSELF WITH THE STERILE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21988675 ↗MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS BLOOD OVERFLOWING FROM THE PART OF THE NEEDLE THAT WAS INSIDE OF THE VACUTAINER (THAT PUNCTURED THE VIALS), WHICH THEN CAUSED THE BLOOD TO OVERFLOW ONTO THE TUBES ITSELF. THERE WAS NO DELAY IN THERAPY. THERE WAS NO MEDICATION USED WITH THIS PRODUCT. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21546098 ↗MalfunctionAug 17, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT AFTER INSERTING THE BLOOD TUBE INTO THE HUB, THE BLOOD FLOWED BACK INTO THE PATIENT'S ARM RATHER THAN COLLECTING PROPERLY IN THE TUBE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19998761 ↗MalfunctionJul 12, 2023Fail-Safe Problem; Fail-Safe Did Not Operate; Fail-Safe Problem; Fail-Safe Did Not Operate
IT WAS REPORTED THAT THE COVER SHEATH THAT IS PROTECTING THE NEEDLE MAY HAVE FALLEN OFF. PATIENT INVOLVEMENT UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17312516 ↗
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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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