Jelco 432215Recalls & 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00351688071029), received between Aug 22, 2024 and Nov 11, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 reports).
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
- Fluid/Blood Leak6
- Disconnection2
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO PULL-OUT MEDICATIONS COMPLETELY WHILE IN USE ON THE PATIENT. THE MEDICATION SEEMED TO LEAK OUT ON THE BACK OF THE SYRINGE. THERE WERE NO PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23522333 ↗MalfunctionFeb 26, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO PULL-OUT MEDICATIONS COMPLETELY WHILE IN USE ON THE PATIENT. THE MEDICATION SEEMED TO LEAK OUT ON THE BACK OF THE SYRINGE. THERE WERE NO PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21474054 ↗MalfunctionDec 2, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE SYRINGE WAS LEAKING AROUND THE PLUNGER. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20818866 ↗MalfunctionNov 8, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT MEDICATION LEAKED OUT AND DID NOT GET TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20640916 ↗MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE MEDICATION WAS SEEPING AROUND THE PLUNGER (LIKE IT IS NOT A TIGHT SEAL). THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20493838 ↗MalfunctionOct 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT MEDICATION WAS SEEPING AROUND THE PLUNGER (LIKE IT IS NOT A TIGHT SEAL). THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20485877 ↗MalfunctionAug 22, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT LOT NUMBER 4141022 FOR PRODUCT NUMBER 432215 HAS HALF-ML INCREMENTS MARKED ON THE SYRINGE, BUT NEW LOT NUMBER 4141024 FOR THE SAME PRODUCT NUMBER DOES NOT. THE FAULT WAS DISCOVERED UPON OPENING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20023928 ↗
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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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