Jelco 306201Recalls & 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 10351688071200), received between Jan 12, 2024 and May 14, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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
- Difficult to Insert1
- Dull, Blunt1
- Patient-Device Incompatibility1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE TEAM FROM HOSPITAL DAS CLINICAS DE PORTO ALEGRE, THAT THE DEVICES WERE "VERY BAD AT PROGRESSING INTO THE PATIENT'S VEIN". SEVEN (7) DEVICES WERE USED. SEVEN (7) ATTEMPTS ON A PATIENT WITH A GOOD VENOUS NETWORK. NO REGULATORY AUTHORITY WAS ADVISED. THE EVENT OCCURRED DURING PATIENT USE AND THERE WAS NO PATIENT HARM. THE PATIENT WAS EXPOSED TO CATHETER EXCHANGE AND TO NEW PUNCTURES. THERE WAS A THERAPEUTIC DELAY AND RISK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19313409 ↗MalfunctionJan 12, 2024Difficult to Insert; Dull, Blunt; Difficult to Insert; Dull, Blunt
IT WAS REPORTED THAT THE MATERIAL SHOWED A DROP IN QUALITY AND PRESENTED GREATER DIFFICULTY IN PUNCTURING VEINS, EVEN EASY PUNCTURES, DUE TO THE NEEDLE THREAD. THERE WAS PATIENT INVOLVEMENT. IT WAS STATED THAT THERE WAS PATIENT HARM SINCE THE PATIENT WAS EXPOSED TO CATHETER EXCHANGE, NEW PUNCTURE, AND THERAPEUTIC DELAY AND RISK. THE AFFECTED PRODUCT IS NOT AVAILABLE FOR EVALUATION.
Patient problems: Insufficient Information
MAUDE report 18505818 ↗
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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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