Jelco 328500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688081933), received between Jan 31, 2018 and Nov 10, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE LEAKED BLOOD IMMEDIATELY UPON THE REMOVAL OF THE SAFETY MECHANISM INSTEAD OF VALVING OFF THE BLOOD AS INTENDED. THEREFORE, BLOOD LEAKED ALL OVER THE PATIENT'S ARM AND BEDDING. THE ISSUE OCCURRED MULTIPLE TIMES. THERE WERE NO SERIOUS HARM AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23515950 ↗
• MalfunctionOct 23, 2025Fluid/Blood Leak; Material Separation; Obstruction of Flow; Fluid/Blood Leak; Material Separation; Obstruction of Flow

  IT WAS REPORTED THAT, WHEN THE NEEDLE WAS REMOVED POST CATHETER ADVANCEMENT, A METAL PIECE WAS NOTED AT THE END OF IV NEEDLE AND THERE APPEARED TO BE THE BLOOD CONTROL VALVE THAT SHOULD BE INSIDE HUB OF THE CATHLON. PER REPORTER, THE IV CATH WAS FLUSHED SUCCESSFULLY. REPORTER ALLEGED THAT, WHEN NOT FLUSHING, BLOOD APPEARED TO BE LEAKING OUT OF IV CATH/HUB. REPORTER STATED THE IV WAS REMOVED AND IT WAS FOUND THE LONG CATHLON PORTION WAS NOT ATTACHED TO END OF HUB. PHYSICAL OCCLUSION OCCURRED WITH IV REMOVAL AND IN THE PROCESS THE LONG CATHLON PORTION OF IV REMAINED IN THE VEIN. REPORTER STATED THEY WERE ABLE TO PULL OUT THE CATHLON PORTION, BUT WERE UNABLE TO CONFIRM IF ALL PLASTIC WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23366711 ↗
• MalfunctionAug 16, 2023Fitting Problem; Material Twisted/Bent; Fitting Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE IV CATHETER TWISTED, DUE TO AN ILL FITTING HUB TO THE TUBING. THIS CAUSED THE IV TO DISLODGE AND THE SKIN SITE TO TEAR. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Skin Tears

  MAUDE report 17560351 ↗
• MalfunctionSep 6, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CATHETER WAS RIDGED AND DIFFICULT TO CHANNEL. THE DEVICE WAS UNABLE TO INSERT EASILY AND THE PATIENT SKIN CONTACT CAUSING PAIN AND BURNING IN THE VEIN: NO MEDICAL OR SURGICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15360385 ↗
• MalfunctionFeb 4, 2022Break; Break

  IT WAS REPORTED THAT AFTER STARTING THE IV THE REPORTER WAS UNABLE TO HOOKUP THE IV LINE DUE TO PART OF THE PLASTIC CATHETER BREAKING OFF INSIDE THE GREEN CANNULA THAT WAS INSERTED INTO THE PATIENTS VEIN. THE ENTIRE GREEN CANNULA WAS PROMPTLY REMOVED FROM THE PATIENTS ARM AND THEN THE PATIENT NEEDED ANOTHER IV START. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13455873 ↗
• MalfunctionJan 31, 2018Delivery System Failure; Delivery System Failure

  AN EMERGENCY DEPARTMENT NURSE REPORTED THAT A JELCO® VIAVALVE® SAFETY IV CATHETER WAS DIFFICULT TO THREAD FORWARD, REQUIRING TWO HANDS TO GET ENOUGH PRESSURE FOR FORWARD MOTION. THIS OFTEN RESULTS IN "BLOWING THE VEIN" AND THE "PATIENT HAS TO BE STUCK AGAIN". THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7232441 ↗

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,