Jelco 326600Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688077431), received between Mar 27, 2020 and May 20, 2020 — classified as 2 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Material Fragmentation1
- Material Separation1
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2020Fluid/Blood Leak; Material Fragmentation; Fluid/Blood Leak; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO VIAVALVE SAFETY IV CATHETER WAS LEAKING BLOOD AT THE INSERTION SITE. THE CATHETER WAS REPORTED TO BE DETACHED AT THE HUB. AN ULTRASOUND WAS PERFORMED REVEALING THAT THE CATHETER WAS NOTED INSIDE THE ANTECUBITAL VEIN OF THE LEFT ARM. SUBSEQUENTLY, THE CATHETER WAS OBTAINED UNDER SURGICAL REMOVAL AND THE CATHETER WAS DISCARDED. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 10074303 ↗InjuryMar 27, 2020Material Separation; Material Separation
INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL JELCO® VIAVALVE® SAFETY IV CATHETER, THE END CAME OFF AND THE CATHETER STAYED IN THE VEIN. IT WAS REPORTED THAT BLEEDING HAD STARTED AROUND THE INSERTION SITE AND THE IV WAS ATTEMPTED TO BE REMOVED. SUBSEQUENTLY, THE CATHETER WAS THEN REMOVED FROM THE PATIENT'S SKIN. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 9887347 ↗
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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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