Jelco 326500Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688077417), received between Jun 19, 2018 and Jun 6, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Fluid/Blood Leak1
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.
MalfunctionJun 6, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT BLOOD LEAKING THROUGH THE VALVE. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. THE EVENT OCCURRED DURING WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19476345 ↗MalfunctionJun 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated
INFORMATION WAS RECEIVED THAT THE PIVC CANNULA DETACHED AND REMAINED WITHIN THE PATIENT. ITEM WAS REMOVED BY PHYSICIAN AT THE BEDSIDE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7615525 ↗
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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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