Jelco 3263Recalls & reported problems
Icu Medical, Inc. · GTIN for VIAVALVE 24G X 5/8 Z 1EA · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical Jelco ViaValve is a short-term peripheral IV catheter with a safety valve. The 53 reports mostly describe a flimsy catheter that bends or kinks during insertion and leaks blood or fluid where the plastic meets the hub, sometimes forcing staff to make repeated punctures. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 15019517078404), received between Aug 10, 2017 and Apr 10, 2026 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (30 reports).
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.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Positioning30
- Material Integrity Problem30
- Structural Problem30
- Difficult to Advance5
- Fluid/Blood Leak5
- Manufacturing, Packaging or Shipping Problem4
- Leak/Splash3
- Defective Device2
Patient problems
- Pain30
- No Clinical Signs, Symptoms or Conditions11
- No Consequences Or Impact To Patient5
- No Known Impact Or Consequence To Patient4
- Discomfort2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 10, 2026Fluid/Blood Leak
AN EVENT INVOLVED A JELCO VIAVALVE SAFETY IV CATHETER WHERE IT WAS REPORTED THAT THE IV (INTRA-VENOUS) CATHETER IS SUPPOSED TO BE LEAKPROOF, BUT THE FLUID DOES NOT DRAIN INTO THE CATHETER. INSTEAD, IT LEAKS BETWEEN THE TIP AND THE ATTACHED PART. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839412 ↗MalfunctionMar 16, 2026Obstruction of Flow
IT WAS REPORTED THAT A JELCO VIAVALVE SAFETY IV CATHETER HAD A NEEDLE THAT APPEARED DULL AND A CATHETER THAT WAS PINCHED AT THE END, PREVENTING FLOW WHEN STARTING AN IV ON A CHILD. THIS OCCURRED MULTIPLE TIMES. THE EVENT OCCURRED WHILE THE PRODUCT WAS IN USE WITH A PATIENT. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605508 ↗MalfunctionDec 8, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PLASTIC PIECE OF THE CATHLON IS VERY FLIMSY. THE TECHNICIANS ARE UNABLE TO ADVANCE THE CATHLON WITHOUT IT BENDING/KINKING WHICH CAUSES MISSED IV ATTEMPTS AND MORE POKES FOR THE PATIENTS. IT REQUIRED THE PATIENT NEEDING MULTIPLE POKES FOR IV ATTEMPTS DUE TO THE CATHETER BENDING EASILY WITH INSERTION. THE PATIENT NEEDED GAUZE COMPRESSION TO STOP BLEEDING CAUSED TRAUMA TO PEDIATRIC PATIENTS WHEN NEEDING MULTIPLE ATTEMPTS TO START AN IV. THERE WAS NO PATIENT HARM/ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743263 ↗MalfunctionOct 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT VIAVALVE IVS HAD BEEN LEAKING BLOOD AFTER INSERTION AND BEFORE THE TUBING WAS CONNECTED. THE EVENT OCCURRED DURING IV INSERTION. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23300984 ↗MalfunctionMay 21, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT HEALTH PROFESSIONAL INSERTED VIA VALVE INTO VEIN-BLOOD STARTED LEAKING OUT BETWEEN WHERE PLASTIC CANULA JOINED HUB. THE IV WAS IMMEDIATELY REMOVED. PATIENT RECEIVED A SECOND IV INSERTION WITH NO ISSUES/LEAKING. THERE WAS MINIMAL HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066234 ↗MalfunctionMay 6, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT UPON STARTING THE PIV, IT STARTED LEAKING BLOOD WHERE THE PLASTIC CATHETER MEETS THE HUB OF THE 24G PIV. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21973217 ↗MalfunctionMay 1, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT UPON STARTING THE PERIPHERAL INTRAVENOUS LINE (PIV), IT STARTED LEAKING BLOOD WHERE THE PLASTIC CATHETER MEETS THE HUB OF THE 24G PIV. THERE WAS A PATIENT INVOLVEMENT, AND NO ADVERSE EFFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21945566 ↗MalfunctionNov 12, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT THE 24G IV VALVE WAS INSERTED INTO THE PATIENT¿S ARM FOR A ZOMETA INFUSION. THE IV WAS LEAKING AT THE HUB OF THE MEDICAL DEVICE. ALTHOUGH THE IV WAS IN THE VEIN, IT WAS LEAKING DUE TO A HOLE OR DEFECT AT THE HUB. THE LEAK APPEARED TO BE WHERE THE HUB MEETS THE PLASTIC CANNULA AT THE BEGINNING OF THE CANNULA (NOT THE END). THE IV WAS REMOVED, AND A NEW IV HAD TO BE STARTED DUE TO THIS DEFECT. AS A RESULT, THE PATIENT REQUIRED AN ADDITIONAL IV POKE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662774 ↗MalfunctionJul 12, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE CUSTOMER HAD A PLASTIC CATHETER SPLIT INTO 2 WHILE TRYING TO THREAD IT INTO THE PATIENT'S VEIN; WITH IV NEEDLE INTACT. WRITER WAS UNABLE TO THREAD AND PULL OUT THE CATHETER. ADVERSE EFFECTS HAVE NOT BEEN REPORTED. IT HAS BEEN REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.
Patient problems: Insufficient Information
MAUDE report 17305867 ↗MalfunctionMay 5, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT UPON INITIATION INTO VEIN BLOOD WAS LEAKING OUT OF SITE, IV REMOVED AND FLUSHED AND NOTED LEAKING FROM THE MIDDLE OF CANNULA. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16876275 ↗MalfunctionSep 20, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE VIA VALVE IV LEAKED BLOOD WHEN NEEDLE RETRACTED AND REMOVED FROM CANNULA. BLOOD LEAKED FROM IV SITE UNEXPECTEDLY. NO PATIENT INJURY WAS REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15454740 ↗MalfunctionMay 12, 2022Defective Device; Defective Device
IT WAS REPORTED THAT THE SAFETY DEVICE OF THE INTRAVENOUS (IV) CATHETER MALFUNCTIONED DURING EACH IV STICK ATTEMPTED, LEAVING THE NEEDLE EXPOSED AND THE VEIN BLOWN. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14383408 ↗MalfunctionMay 7, 2018Fail-Safe Design Failure; Fail-Safe Design Failure
IT WAS REPORTED THAT WHEN THE NEEDLE OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS INSERTED AND HUB REMOVED, BLOOD STARTED. NO REPORT OF PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7492553 ↗MalfunctionApr 12, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE INTRAVENOUS CATHLON OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS LONGER THAN THE INTRAVENOUS NEEDLE. THE CLINICIAN WAS UNABLE TO VENIPUNCTURE SAFELY. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7424790 ↗MalfunctionApr 12, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE INTRAVENOUS CATHLON OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS LONGER THAN THE INTRAVENOUS NEEDLE. THE CLINICIAN WAS UNABLE TO VENIPUNCTURE SAFELY. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7424752 ↗MalfunctionApr 12, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE INTRAVENOUS CATHLON OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS LONGER THAN THE INTRAVENOUS NEEDLE. THE CLINICIAN WAS UNABLE TO VENIPUNCTURE SAFELY. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7424746 ↗MalfunctionApr 12, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE INTRAVENOUS CATHLON OF A JELCO® VIAVALVE® SAFETY IV CATHETER WAS LONGER THAN THE INTRAVENOUS NEEDLE. THE CLINICIAN WAS UNABLE TO VENIPUNCTURE SAFELY. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7424740 ↗MalfunctionMar 29, 2018Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE SMITHS MEDICAL DEVICE "BLOOD RETURN BIG VEINS" AND THE DEVICE WAS HARD TO SLIDE. IT WAS INDICATED THAT A NURSE BLEW A VEIN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7381767 ↗MalfunctionMar 29, 2018Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE SMITHS MEDICAL DEVICE "BLOOD RETURN BIG VEINS" AND THE DEVICE WAS HARD TO SLIDE. IT WAS INDICATED THAT A NURSE BLEW A VEIN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7381763 ↗MalfunctionMar 29, 2018Difficult to Advance; Difficult to Advance
IT WAS REPORTED THAT THE SMITHS MEDICAL DEVICE "BLOOD RETURN BIG VEINS" AND THE DEVICE WAS HARD TO SLIDE. IT WAS INDICATED THAT A NURSE BLEW A VEIN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7381758 ↗MalfunctionMar 13, 2018Dull, Blunt; Difficult to Advance; Dull, Blunt; Difficult to Advance
INFORMATION WAS RECEIVED INDICATING THAT CLINICIANS IN THE FIELD HAVE NOTED THAT THIS NEEDLE APPEARED TO BE DULL. THE NURSES FOUND DIFFICULTY PIERCING THE SKIN WITH THE NEEDLE. IT WAS ALSO NOTED THAT THE PATIENT FELT DISCOMFORT AND THAT THE NEEDLE WOULD NOT ADVANCE INTO THE VEIN. PRESSURE WAS APPLIED TO THE SITE TO STOP ANY BLEEDING AFTER PIERCING THE SKIN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Discomfort
MAUDE report 7334434 ↗MalfunctionMar 13, 2018Dull, Blunt; Difficult to Advance; Dull, Blunt; Difficult to Advance
INFORMATION WAS RECEIVED INDICATING THAT CLINICIANS IN THE FIELD HAVE NOTED THAT THIS NEEDLE APPEARED TO BE DULL. THE NURSES FOUND DIFFICULTY PIERCING THE SKIN WITH THE NEEDLE. IT WAS ALSO NOTED THAT THE PATIENT FELT DISCOMFORT AND THAT THE NEEDLE WOULD NOT ADVANCE INTO THE VEIN. PRESSURE WAS APPLIED TO THE SITE TO STOP ANY BLEEDING AFTER PIERCING THE SKIN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Discomfort
MAUDE report 7334432 ↗MalfunctionFeb 20, 2018Difficult or Delayed Positioning; Structural Problem; Material Integrity Problem; Difficult or Delayed Positioning; Structural Problem; Material Integrity Problem
INFORMATION WAS RECEIVED INDICATING THAT THIS PERIPHERAL INTRAVENOUS CATHETER'S NEEDLE SHAFT WAS NOT STURDY, THAT THE TWO PIECES WERE FLEXIBLE AND WIGGLE, AND THAT THE NEEDLE SCRAPES AGAINST THE SHAFT WHEN RETRACTING. IT WAS ALSO NOTED THAT THE END WAS BLUNT AND THAT THE VALVE DOES NOT OPEN. THE PATIENT EXPERIENCED PAIN DURING THE USE OF THIS CATHETER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pain
MAUDE report 7282690 ↗MalfunctionFeb 20, 2018Difficult or Delayed Positioning; Structural Problem; Material Integrity Problem; Difficult or Delayed Positioning; Structural Problem; Material Integrity Problem
INFORMATION WAS RECEIVED INDICATING THAT THIS PERIPHERAL INTRAVENOUS CATHETER'S NEEDLE SHAFT WAS NOT STURDY, THAT THE TWO PIECES WERE FLEXIBLE AND WIGGLE, AND THAT THE NEEDLE SCRAPES AGAINST THE SHAFT WHEN RETRACTING. IT WAS ALSO NOTED THAT THE END WAS BLUNT AND THAT THE VALVE DOES NOT OPEN. THE PATIENT EXPERIENCED PAIN DURING THE USE OF THIS CATHETER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pain
MAUDE report 7282686 ↗MalfunctionFeb 20, 2018Difficult or Delayed Positioning; Structural Problem; Material Integrity Problem; Difficult or Delayed Positioning; Structural Problem; Material Integrity Problem
INFORMATION WAS RECEIVED INDICATING THAT THIS PERIPHERAL INTRAVENOUS CATHETER'S NEEDLE SHAFT WAS NOT STURDY, THAT THE TWO PIECES WERE FLEXIBLE AND WIGGLE, AND THAT THE NEEDLE SCRAPES AGAINST THE SHAFT WHEN RETRACTING. IT WAS ALSO NOTED THAT THE END WAS BLUNT AND THAT THE VALVE DOES NOT OPEN. THE PATIENT EXPERIENCED PAIN DURING THE USE OF THIS CATHETER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: Pain
MAUDE report 7282683 ↗
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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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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