Jelco 3073Recalls & reported problems
Icu Medical, Inc. · GTIN for PROTECTIVE W SAFETY IV CATHETER - RADIOPAQUE 24G 1/EA · Class 2
Quick summary
This ICU Medical Jelco 3073 protective IV catheter is a short-term safety needle used for IV therapy. Reports mostly describe the catheter tip fraying, bending or splitting as it is inserted, sometimes so the needle poked through the tip and blood would not flush; some catheters were bent or torn straight from the packaging. There are 33 reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10351688071293), received between Aug 7, 2018 and Sep 23, 2024 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (28 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
- Material Twisted/Bent28
- Material Frayed19
- Material Perforation18
- Material Split, Cut or Torn7
- Contamination /Decontamination Problem3
- Mechanical Problem3
- Obstruction of Flow3
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient3
- Insufficient Information2
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2024Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THERE WERE TWO ATTEMPTS AT IV THERAPY, BOTH OF WHICH WERE SUCCESSFUL IN RECOVERING BLOOD, BUT IT WAS NOT FLUSHING. THE END OF CATHETER WAS SPREAD AFTER REMOVAL. THEY PULLED 2 MORE UNUSED FROM SUPPLY ROOM AND BOTH OF THOSE WERE DEFECTIVE ALSO. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20280894 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14147713 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14147709 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14147627 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14147357 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14147177 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14146800 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14146591 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14146293 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14145957 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14145630 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14144655 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14144015 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14143655 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14143242 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14143016 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14142936 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14142757 ↗MalfunctionApr 19, 2022Material Frayed; Material Perforation; Material Twisted/Bent; Material Frayed; Material Perforation; Material Twisted/Bent
IT WAS REPORTED THAT THE CATHETER TIPS WERE FRAYING UPON INSERTION. THE NEEDLE WAS POKING THROUGH CATHETER TIP. THE NEEDLE TIP WAS BENT PRIOR TO PACKAGES BEING OPENED AND THE CATHETER WAS FLIMSY ENOUGH TO BE BENT WITH AIR BLOWING ON IT, CAUSING MULTIPLE STICKS UPON INSERTION. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14142644 ↗MalfunctionApr 15, 2022Material Puncture/Hole
HOLE NOTED IN IV CATHETER TIP DURING IV INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14117725 ↗MalfunctionApr 12, 2022Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE SHEATH WAS BENT, THE CATHETER CREASED AND WOULD NOT ALLOW THE NEEDLE TO RETRACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14089080 ↗MalfunctionMar 31, 2022Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
IT WAS REPORTED THAT THE WHITE CATHETER PIECE HAS EITHER BEEN BENT OR TORN BEFORE USE OR HAS FAILED UPON USE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13969074 ↗MalfunctionMar 31, 2022Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
IT WAS REPORTED THAT THE WHITE CATHETER PIECE HAS EITHER BEEN BENT OR TORN BEFORE USE OR HAS FAILED UPON USE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13968058 ↗MalfunctionMar 31, 2022Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
IT WAS REPORTED THAT THE WHITE CATHETER PIECE HAS EITHER BEEN BENT OR TORN BEFORE USE OR HAS FAILED UPON USE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13967801 ↗MalfunctionMar 31, 2022Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn
IT WAS REPORTED THAT THE WHITE CATHETER PIECE HAS EITHER BEEN BENT OR TORN BEFORE USE OR HAS FAILED UPON USE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13967670 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.