Jelco 405011Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315118333), received between Mar 24, 2022 and May 11, 2026 — classified as 2 injuries, 3 malfunctions.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Defective Component1
- Detachment of Device or Device Component1
- Difficult to Remove1
- Material Separation1
- Material Too Soft/Flexible1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THEY PLACED 22 GAUGE IV IN THE LEFT FOOT. THE LINE WOULD NOT FLUSH SO THEY DECIDED TO REMOVE THE CATHETER WHILE CONTINUING TO LOOK FOR IV ACCESS ON THE OTHER LIMBS. AS THEY REMOVED THE CATHETER, THEY HEARD A POP AND INSPECTED THE REMAINING PIECE OF THE CATHETER AS IT LOOKED SHORT. THEY LOOKED AT THE SITE AND DID NOT SEE ANY OF THE REMAINING PIECE OF THE CATHETER AT THE INSERTION SITE, ON THE BED OR ON THE NEARBY 4X4S. WHILE WAITING FOR GENERAL SURGERY, THEY DID THE ENT PORTION OF THE CASE AND ALSO LOOKED AT THE INSERTION SITE WITH THE ULTRASOUND. ALL PARTS OF THE FOREIGN BODY OF THE CATHETER WERE REMOVED AND INTACT. THERE WAS A DELAY OF THERAPY. PROLONGED ANESTHESIA DUE TO SURGICAL REMOVAL OF RETAINED PIECE OF CATHETER. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS A PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25135398 ↗MalfunctionMay 8, 2026Material Separation; Defective Component
IT WAS REPORTED THAT THEY NOTICED THE CATHETER SHEARED AWAY FROM THE NEEDLE DURING REMOVAL/END OF THERAPY. THERE WAS A MEDICAL INTERVENTION REQUIRED. THIS DAMAGE COULD CAUSE HARM TO THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125077 ↗MalfunctionMay 8, 2026Difficult to Remove
IT WAS REPORTED THAT THE CATHETER WAS UNABLE TO REMOVE, IT WAS STUCK. AFTER REMOVAL, THEY NOTICED THE CATHETER TIP WAS MISSING. MEDICAL INTERVENTION WAS REQUIRED. THE REPORTED ISSUE COULD CAUSE SERIOUS HARM TO THE PATIENT. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS A PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125054 ↗InjuryAug 22, 2025Break; Break
IT WAS REPORTED THAT THE PERIPHERAL INTRAVENOUS LINE WAS ATTEMPTED IN THE LEFT AC AND, WHEN THE CATHETER WAS PULLED OUT, THE TIP WAS FOUND TO BE SHEARED OFF. PER REPORTER, AN X-RAY WAS DONE, AND THE PORTION OF THE DEVICE WAS SEEN ON THE X-RAY.
Patient problems: Insufficient Information
MAUDE report 22872607 ↗MalfunctionMar 24, 2022Material Too Soft/Flexible; Material Too Soft/Flexible
IT WAS REPORTED THAT THE PLASTIC PORTION OF THE CATHETER, THE THIN TUBE THAT SHOULD BE INSERTED INTO THE PATIENT, CRUMBLES AND BENDS/KINKS; MAKING IT VERY DIFFICULT TO CANNULATE` PATIENT. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13894843 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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