Jelco 401815Recalls & reported problems
Icu Medical, Inc. · Class 2
- 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 00351688070831), received between May 3, 2017 and Aug 29, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Missing” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Component Missing1
- Protective Measures Problem1
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.
MalfunctionAug 29, 2022Component Missing; Component Missing
IT WAS REPORTED THAT THE SYRINGE WAS MISSING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15311122 ↗MalfunctionMay 3, 2017Protective Measures Problem; Protective Measures Problem
IT WAS REPORTED THAT IMMEDIATELY UPON USE, THE SAFETY DEVICE OF A NEW JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ "GOT IN THE WAY" WHILE INJECTING. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6541819 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.