Jelco 3265Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15019517078411), received between Jun 5, 2018 and Jul 26, 2024 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT AFTER USE ON PATIENT, THE PARAMEDIC PUSHED THE SHIELDED VIAVALVE INTO THE SHARPS CONTAINER WHEN THE POINT OF THE NEEDLE BECAME UNSHIELDED AND STUCK THE PARAMEDIC. THIS OCCURRED A TOTAL OF 3 TIMES. THE PRODUCT WAS NOT CONTAMINATED NOR CONTAINED A BIOHAZARD OR CHEMOTHERAPEUTIC AGENT. THE HEALTHCARE PROVIDER WAS REPORTED HARMED DUE TO THE NEEDLESTICK. THERE WAS NO DELAY IN THERAPY TO THE PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 19838729 ↗
• MalfunctionAug 26, 2022Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS PLACED IN THE PATIENT AND THE TIP OF THE NEEDLE BROKE OFF IN THE CATHETER. THE NURSE REMOVED THE SYRINGE AND THE TIP OF THE NEEDLE FROM THE IV WAS ON THE TIP OF THE SYRINGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15305161 ↗
• InjuryJan 6, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT IN THE EMERGENCY ROOM A NURSE INSERTED 18G IV INTO PATIENT'S LEFT ANTECUBITAL FOSSA. IV INFILTRATED. LABS DRAWN OFF IT. WHILE TRYING TO REMOVE IV CATHETER, CATHETER GOT STUCK. MEDIC AT THE BEDSIDE STARTED TO PULL CATHETER OUT. PART OF CATHETER TIP APPEARS TO HAVE SHEARED OFF INTO THE VEIN. CATHETER MEASURED AND APPROXIMATELY 6MM OF CATHETER IS BELIEVED TO BE LEFT INSIDE OF PATIENTS ARM. SURGEON SUCCESSFULLY REMOVED APPROXIMATELY 0.3CM OF RETAINED CATHETER. NO COMPLICATIONS AND PATIENT WAS DISCHARGED THE NEXT DAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11127664 ↗
• InjurySep 18, 2018Disconnection; Connection Problem; Disconnection; Connection Problem

  IT WAS REPORTED THAT WHEN THE OPERATOR TRIED TO REMOVE THE NEEDLE AND CATHETER, IT REMAINED IN THE PATIENT. THE PRODUCT WAS EVENTUALLY REMOVED. THE PATIENT EXPERIENCED MINOR INJURY AS A RESULT.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 7887208 ↗
• MalfunctionAug 14, 2018Product Quality Problem; Dull, Blunt; Product Quality Problem; Dull, Blunt

  IT WAS REPORTED THAT THE STAFF WERE EXPERIENCING DIFFICULTY STARTING THE IVS. THE CATHETERS APPEARED DULL AND FAILED TO ADVANCE. IT WAS FURTHER REPORTED THAT THE PATIENTS EXPERIENCED PAIN UPON INSERTION. NO FURTHER COMPLICATION WERE REPORTED, AND NO MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 7782570 ↗
• MalfunctionJun 27, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A USER FACILITY HAD DIFFICULTY STARTING AN IV DUE TO THE NEEDLE APPEARING DULL AND THE CATHETER NOT ADVANCING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643440 ↗
• MalfunctionJun 27, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A USER FACILITY HAD DIFFICULTY STARTING AN IV DUE TO THE NEEDLE APPEARING DULL AND THE CATHETER NOT ADVANCING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643421 ↗
• MalfunctionJun 27, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT A USER FACILITY HAD DIFFICULTY STARTING AN IV DUE TO THE NEEDLE APPEARING DULL AND THE CATHETER NOT ADVANCING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7643414 ↗
• MalfunctionJun 7, 2018Difficult to Advance; Difficult to Advance

  INFORMATION WAS RECEIVED INDICATING THAT THIS PERIPHERAL INTRAVENOUS CATHETER WAS DRAGGING UPON THREADING THE NEEDLE. THE DIFFICULT INSERTION CAUSED VEINS TO BLOW AND REQUIRED ADDITIONAL POKES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579589 ↗
• MalfunctionJun 5, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE NURSE EXPERIENCED A DRAG WHEN TREADING THE CATHETER FORWARD, CAUSING THE VEIN TO BLOW AND NEEDING TO POKE THE PATIENT AGAIN. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7570849 ↗
• MalfunctionJun 5, 2018Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE NURSES WERE COMPLAINING OF A DRAG WHEN THREADING THE CATHETER FORWARD. THEY ALLEGED THAT THIS EITHER CAUSED THE VEINS TO BLOW, OR REQUIRED HAVING TO POKE THE PATIENT AGAIN. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: Infiltration into Tissue

  MAUDE report 7570847 ↗
• MalfunctionJun 5, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT THE VIAVALVE CATHETER UTILIZED BY THE RN'S ARE COMPLAINING OF A DRAG WHEN THREADING THE CATHETER FORWARD. CAUSING VEINS TO BLOW OR HAVING TO POKE THE PATIENT AGAIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7570835 ↗

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 pyrogeni