Jelco 335503Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688071422), received between Sep 15, 2021 and Sep 15, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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
- Physical Resistance/Sticking1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2021Physical Resistance/Sticking; Physical Resistance/Sticking
INFORMATION WAS RECEIVED INDICATING THAT AT THE END OF THERAPY WITH A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY ACUVANCE PLUS CATHETER, THE NEEDLE WAS FOUND TO BE UNSMOOTH AND THERE WAS A FEELING OF ADHESION TO THE BLOOD VESSELS. IT WAS ALSO REPORTED THAT NEEDLE CATHETERS WERE REDUCED BY HALF AFTER PRESSED THE VESSELS. IT WAS NOTED THAT X-RAY EXAMINATION WAS PERFORMED, AND THE STUMP CATHETER WAS FOUND IN THE BODY. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED PAIN. NO FURTHER ADVERSE EFFECTS WERE REPORTED.
Patient problems: Pain
MAUDE report 12473992 ↗
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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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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