Jelco 446611Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315118548), received between Oct 17, 2018 and Oct 17, 2018 — classified as 1 injury.
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
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 17, 2018Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT WHILE THE NURSE WAS ATTEMPTING TO PULL OUT A SMITHS MEDICAL JELCO® CATHLON® I.V. CATHETER, THE PLASTIC PART BROKE OFF IN THE PATIENT. IT WAS REPORTED THAT APPROXIMATELY 2MM OF THE PLASTIC CAME OUT. SUBSEQUENTLY, THE PATIENT HAD THE SEVERED CATHETER REMOVED IN INTERVENTIONAL RADIOLOGY. THERE WERE NO FURTHER REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 7975531 ↗
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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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