Jelco 335703Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688071453), received between Apr 19, 2018 and May 22, 2018 — classified as 2 injuries.
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 (K012128); 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
- Difficult to Remove1
- Disconnection1
Patient problems
- Foreign Body In Patient1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2018Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component
IT WAS REPORTED THAT UPON DISCONTINUING AN IV PLACED IN THE LEFT ANTECUBITAL SITE, A PERIPHERAL INTRAVASCULAR CATHETER BECAME DETACHED FROM THE HUB WHEN ATTEMPTING TO REMOVE THE DEVICE AND THE CATHETER REMAINED IN THE PATIENT. THE DETACHED CATHETER REQUIRED MEDICAL INTERVENTION BUT NO PATIENT INJURY WAS ASSOCIATED WITH THIS INCIDENCE.
Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient
MAUDE report 7531812 ↗InjuryApr 19, 2018Difficult to Remove
UPON DISCONTINUING THE IV IN THE LEFT ANTECUBITAL SITE, NO CATHETER CAME WITH THE HUB. DATES OF USE: (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: IV THERAPY.
Patient problems: No Information
MAUDE report 7446357 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K012128. One submission often covers many models, so check the product and lot details in each record.
- Z-0789-2017 · Nov 21, 2016 · TerminatedAcuvance2 Safety Catheter, Product No. 1720-AI Product Usage: The Acuvance 2 Safety Catheter is a Peripheral Intravenous Catheter (PIVC). PIVCs are designed for single use venipun
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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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