Jelco 405511Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315118364), received between Jan 15, 2020 and Mar 24, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
- Material Too Soft/Flexible1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2022Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE PLASTIC PORTION OF THE CATHETER, THE THIN TUBE THAT SHOULD BE INSERTED INTO THE PATIENT, CRUMBLES AND BENDS/KINKS; MAKING IT VERY DIFFICULT TO CANNULATE` PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13892834 ↗InjuryJan 15, 2020Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® IV CATHETER SEVERED IN A PATIENT'S ARM. THE SEVERED PIECE OF CATHETER WAS SUCCESSFULLY SURGICALLY REMOVED. THERE WERE NO FURTHER ADVERSE EFFECTS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9594310 ↗
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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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