Jelco 328200Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688081926), received between Sep 16, 2021 and Sep 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 other recall cover devices cleared under the same FDA submission (K160235); they may or may not involve this specific model.
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
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY VIAVALVE CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT AC VEIN. FOLLOWING THIS THE CATHETER THEN DETACHED FROM THE REST OF THE IV AND WAS INSIDE THE PATIENT'S VEIN AND NOT VISIBLE. IT WAS ALSO REPORTED THAT IT WAS ATTEMPTED TO VISUALIZE THE CATHETER UNSUCCESSFULLY AND THE PATIENT'S VEIN APPEARED TO BURST AS IT BECAME NOTICEABLY MORE SWOLLEN. PATIENT REPORTED NO DISCOMFORT AT THIS TIME. NO FURTHER EFFECTS WERE REPORTED.
Patient problems: Insufficient Information
MAUDE report 12482987 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K160235. One submission often covers many models, so check the product and lot details in each record.
- Z-1218-2019 · Aug 22, 2018 · TerminatedJelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic,
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- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
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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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