Jelco 326000Recalls & 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 10351688077448), received between Oct 10, 2018 and Oct 10, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
- Material Fragmentation1
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 10, 2018Break; Material Fragmentation; Material Integrity Problem; Break; Material Fragmentation; Material Integrity Problem
IT WAS REPORTED THAT DURING THE CATHETER REMOVAL, THE USER NOTED THAT TUBE WAS DAMAGED: A PIECE OF THE TUBE WAS MISSING AT THE DISTAL EXTREMITY. AN X-RAY OF THE LEFT ARM OF THE PATIENT SHOWED THAT A RADIOPAQUE FRAGMENT (CONSISTENT WITH THE MISSING PIECE OF THE CATHETER) WAS PRESENT IN THE ELBOW.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 7953794 ↗
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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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