Jelco 328000Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10351688081964), received between Sep 14, 2021 and Sep 30, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (10 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953910 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE VIA VALVE LEAKED BLOOD WHEN INSERTED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25111737 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE VALVE ON AN IV CATHETER DID NOT ACTIVATE TO PREVENT BLOOD FLOW AFTER INSERTION. THE PATIENT EXPERIENCED FREE FLOW OF BLOOD FROM THE CATHETER UPON INSERTION. NO ADDITIONAL ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25049619 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE OF THE VIAVALVE CATHETER DOES NOT ALWAYS "SELF-OCCLUDE" WITH BLOOD COMING BACK. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24344414 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THE REPORTER ATTEMPTED TO INSERT THE 22G PIV TO RIGHT AC. BLOOD RETURN WAS NOTED, HOWEVER UPON ADVANCEMENT OF THE CATHETER THEY NOTICED LOTS OF RESISTANCE AND COULD SEE THAT CATHETER WAS KINKED UNDERNEATH SKIN, THEREFORE WRITER REMOVED SAME. THE CATHETER WAS NOTED TO BE BROKEN OFF UPON REMOVAL, WITH HALF LODGED IN PATIENT'S SKIN, AT SKIN LEVEL. THE REPORTER NOTED THAT THEY WERE ABLE TO REMOVE THE REMAINDER OF PIV CATHETER WITH NO APPARENT FURTHER BREAKS IN REMAINDER OF CATHETER. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084363 ↗
• MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE DEVICE WAS INSERTED AND NEEDLE WAS RETRACTED INTO THE CHAMBER, BLOOD STARTED LEAKING FROM THE CONNECTION. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829126 ↗
• MalfunctionJun 6, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT HAD A FILTER BLEED, WHICH IS INTENDED TO BE A LINE WHERE BLOOD DOES NOT COME IN CONTACT WITH NURSE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160189 ↗
• MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER INSERTING AN IV AND THE NEEDLE WAS RETRACTED INTO THE CHAMBER, BLOOD STARTED LEAKING FROM THE CONNECTION. THERE WAS PATIENT INVOLVEMENT, WITH NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126662 ↗
• MalfunctionMay 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE IV WAS INSERTED AND NEEDLE WAS RETRACTED INTO THE CHAMBER, BLOOD STARTED LEAKING FROM THE CONNECTION. IN THIS INCIDENCE, BLOOD STARTED RUNNING DOWN THE PATIENT'S ARM. THERE WAS A DELAY TO TREATMENT/THERAPY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075803 ↗
• MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE IV WAS INSERTED, AND THE NEEDLE WAS RETRACTED INTO THE CHAMBER, BLOOD STARTED LEAKING AT THE CONNECTION BETWEEN THE CHAMBER AND THE TIP OF THE IV CATHETER. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027059 ↗
• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER INSERTING AN IV AND RETRACTING THE NEEDLE INTO THE CHAMBER, BLOOD STARTED LEAKING AT THE CONNECTION BETWEEN THE CHAMBER AND THE TIP WHERE THE CATHETER IS CONNECTED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994575 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE WAS RETRACTED INTO THE CHAMBER AND BLOOD STARTED LEAKING FROM THE TIP OF THE CATHETER. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965041 ↗
• MalfunctionNov 14, 2024Leak/Splash; Leak/Splash

  IT WAS STATED THAT WHILE STARTING A PERIPHERAL IV, WRITER NOTICED BLOOD LEAKING FROM THE HUB AFTER THE NEEDLE WAS SECURED IN THE CHAMBER. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED. DEVICE IS AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20690246 ↗
• MalfunctionSep 12, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE IV CATHETERS WERE PUNCTURING THE VEIN ABOVE INSERTION SITE CAUSING THE VEINS TO BLOW DESPITE BLOOD RETURN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403465 ↗
• MalfunctionSep 6, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE IV CATHETERS WERE PUNCTURING THE VEIN ABOVE INSERTION SITE CAUSING THE VEINS TO BLOW DESPITE BLOOD RETURN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15360479 ↗
• MalfunctionSep 6, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE IV CATHETERS WERE PUNCTURING THE VEIN ABOVE INSERTION SITE CAUSING THE VEINS TO BLOW DESPITE BLOOD RETURN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15360412 ↗
• MalfunctionSep 14, 2021Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT UPON INSERTION OF A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY VIAVALVE CATHETER, THE NEEDLE BROKE WHILE STILL IN THE CATHETER. SUBSEQUENTLY, THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469087 ↗

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 · Terminated
  Jelco(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,