Jelco 335903Recalls & 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 10351688071439), received between Feb 20, 2018 and Feb 20, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Material Fragmentation” (1 report).
1 other recall cover devices cleared under the same FDA submission (K012128); they may or may not involve this specific model.
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.
InjuryFeb 20, 2018Material Fragmentation; Material Fragmentation
INFORMATION WAS RECEIVED INDICATING THAT AN ULTRASOUND MACHINE WAS USED TO INSERT A SMITHS MEDICAL JELCO® ACUVANCE® SAFETY I.V. CATHETER. IT WAS REPORTED THAT THE CLINICIAN GOT A FLASH AFTER INSERTION, COULD NOT ADVANCE THE CATHETER, WAS REMOVED WITH NOTED CATHETER SHEARING AT THE END OF THE TIP. AN X-RAY WAS PERFORMED AND REVEALED THAT THE SHEARED CATHETER PIECE WAS IN THE PATIENT'S VEIN. SUBSEQUENTLY, THE CATHETER TIP WAS SURGICALLY REMOVED. INFORMATION WAS NOTED THAT UPON THREADING THE CATHETER FROM THE STYLET, A BLUNT METAL PIECE WAS EXTRACTED FROM THE BEVEL OF THE NEEDLE, AND REDIRECTING THE CATHETER MAKES IT EASIER TO SHEAR THE CATHETER. THERE WAS NO REPORTED ADVERSE EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 7282599 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K012128. One submission often covers many models, so check the product and lot details in each record.
- Z-0789-2017 · Nov 21, 2016 · TerminatedAcuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipun
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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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