Jelco 328700Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10351688081940), received between Dec 20, 2021 and Mar 18, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE LEAK BADLY, CAUSING A BLOOD MESS WHEN INSERTING THE IV (INTRAVENOUS). THERE WERE DELAYS IN THERAPY OR TREATMENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628257 ↗
• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT STAFF TRIED TIGHTENING THE CONNECTION POINT, BUT IT STILL LEAKED. THE EVENT OCCURRED IN THE CLINIC OPERATED BY A HEALTH PROFESSIONAL. NO MEDICAL INTERVENTION WAS REQUIRED, AND NO PATIENT INJURIES OCCURRED. THEY HAD TO REMOVE THE IV AND START A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474952 ↗
• MalfunctionFeb 27, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT STAFF TRIED TIGHTENING THE CONNECTION POINT, BUT IT STILL LEAKED. THE EVENT OCCURRED IN THE CLINIC OPERATED BY A HEALTH PROFESSIONAL. NO MEDICAL INTERVENTION WAS REQUIRED, AND NO PATIENT INJURIES OCCURRED. THEY HAD TO REMOVE THE IV AND START A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474933 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak

  IT WAS REPORTING THAT STAFF TRIED TIGHTENING THE CONNECTION POINT, BUT IT STILL LEAKED. THREE NEEDLES WERE IMPACTED.THE EVENT OCCURRED IN THE CLINIC OPERATED BY A HEALTH PROFESSIONAL. IT WAS NOT REPORTED TO THE FDA. NO MEDICAL INTERVENTION WAS REQUIRED, AND NO PATIENT INJURIES OCCURRED. A SAMPLE VIDEO PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24419064 ↗
• MalfunctionMar 21, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN THE IV WAS REMOVED FROM THE PATIENT IT SLID THE SAFETY LOCK INTO PLACE. THE DEVICE SEEMED TO EXTEND PAST THE LOCK AND EXPOSED THE NEEDLE WHICH EVENTUALLY POKED THE OPERATOR OF THE DEVICE IN THE RIGHT THUMB. THERE WAS UNKNOWN IF EXPOSURE TO HIV/HEP B HAD HAPPENED GIVEN THAT THE PATIENT IS A DRUG USER. THE OPERATOR OF THE DEVICE REPORTED THAT THEY ARE PREGNANT AND THUS WAS NOT ALLOWED TO TAKE PROPHYLACTIC TREATMENT. SEROLOGY WAS DONE WITH NO FURTHER INFORMATION PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21669498 ↗
• MalfunctionMar 6, 2025Fail-Safe Problem; Fail-Safe Problem

  IT WAS REPORTED THAT THE NURSE ATTEMPTED TO COLLECT BLOOD WORK AND STARTED AN INTRAVENOUS LINE TO PATIENT R'S ANTECUBITAL VEIN BUT WAS UNSUCCESSFUL, WRITER REMOVED CANNULA/NEEDLE AND ATTEMPTED TO PUSH UP SAFETY MECHANISM, BUT IT DID NOT GO UP. PATIENT R'S INDEX FINGER WAS POKED WITH THE SAME NEEDLE. THERE WAS MINIMAL LEVEL OF HARM REPORTED WITH SOME BLEEDING AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21533162 ↗
• MalfunctionDec 20, 2021Difficult to Advance; Material Split, Cut or Torn; Difficult to Advance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CATHETER WAS DIFFICULT TO ADVANCE AND THEN SEVERANCE. DEVICE WAS SEVERED ON EMS FIELD HELICOPTER AND THEY WAS UNABLE TO LOCATE PART OF CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049085 ↗

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,