Jelco 3267Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 15019517078435), received between Jul 21, 2017 and Sep 28, 2026 — classified as 3 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (16 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 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924675 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS SPONTANEOUS BLEEDING THAT OCCURRED UPON INTRAVENOUS (IV) INSERTION. REPORTER HAD THE CONCERN BROUGHT FORWARD BY MULTIPLE STAFF MEMBERS AND WAS ABLE TO OBSERVE AN INSERTION WHERE SPONTANEOUS BLEEDING OCCURRED. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216106 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak

  IT WAS STATED THAT THE VALVES MALFUNCTIONED. AFTER INSERTING DEVICE/NEEDLE INTO PATIENT, RETRACTING THE NEEDLE, AND REMOVING RETRACTED NEEDLE FROM THE HUB OF THE INSERTED CATHETER. THE ONE-WAY VALVE FAILED, CAUSING UNEXPECTED BLEEDING OUT OF THE HUB IF THE CLINICIAN DID NOT PERFORM MANUAL TAMPONADE OF THE VEIN. MANUAL TAMPONADE OF VEIN REQUIRED TO STOP BLEEDING, ALTHOUGH THIS IS STANDARD PRACTICE WHEN USING IV CATHETERS THAT DO NOT HAVE ONE-WAY VALVES AT THE HUB. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148986 ↗
• MalfunctionApr 7, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPONTANEOUS BLEEDING UPON CATHETER INSERTION. BLOOD LEAKED FROM THE CONNECTION BETWEEN THE PLASTIC INTRAVENOUS AND THE PINK HUB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808072 ↗
• MalfunctionMar 25, 2026Partial Blockage; Obstruction of Flow; Material Twisted/Bent

  IT WAS STATED THAT THE TIP OF THE CATHETER WAS BENT OR CRUSHED AND BECAME CLOGGED. THE ISSUE ORIGINATED FROM NURSING, AND THERE WERE TWO OCCURRENCES. IT WAS NOT IDENTIFIED WHILE THE PATIENT WAS RECEIVING MEDICATIONS; IT WAS DISCOVERED WHEN THE NURSE WENT TO INITIATE THE IV. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687690 ↗
• MalfunctionMar 25, 2026Partial Blockage; Obstruction of Flow; Material Twisted/Bent

  IT WAS STATED THAT THE TIP OF THE CATHETER WAS BENT OR CRUSHED AND BECAME CLOGGED. THE ISSUE ORIGINATED FROM NURSING, AND THERE WERE TWO OCCURRENCES. IT WAS NOT IDENTIFIED WHILE THE PATIENT WAS RECEIVING MEDICATIONS; IT WAS DISCOVERED WHEN THE NURSE WENT TO INITIATE THE IV. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687118 ↗
• MalfunctionMar 11, 2026Complete Blockage

  IT WAS REPORTED THAT THEY HAD TWO BOXES THAT DID NOT SHOW EARLY CONFIRMATION WITH BLOOD FLASHING UP THE CATHETER. THEY HAD USED THEM FOR OVER A YEAR AND HAD NOT EXPERIENCED THIS ISSUE EXCEPT WITH THIS LOT. THE FAILURE OCCURRED WHILE IT WAS BEING USED ON A PATIENT. FURTHER ATTEMPTS TO GAIN ACCESS WERE UNSUCCESSFUL, AND THE BLOWN VESSELS REQUIRED A COMPRESSION DRESSING. THE PATIENT WAS A MIDDLE-AGED WHITE FEMALE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574525 ↗
• MalfunctionMar 2, 2026Complete Blockage

  IT WAS REPORTED THAT THEY HAD TWO BOXES THAT DID NOT SHOW EARLY CONFIRMATION WITH BLOOD FLASHING UP THE CATHETER. THEY HAD USED THEM FOR OVER A YEAR AND HAD NOT EXPERIENCED THIS ISSUE EXCEPT WITH THIS LOT. THE FAILURE OCCURRED WHILE IT WAS BEING USED ON A PATIENT. FURTHER ATTEMPTS TO GAIN ACCESS WERE UNSUCCESSFUL, AND THE BLOWN VESSELS REQUIRED A COMPRESSION DRESSING. THE PATIENT WAS A MIDDLE-AGED WHITE FEMALE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491159 ↗
• MalfunctionFeb 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS SPONTANEOUS BLEEDING THAT OCCURRED UPON INTRAVENOUS (IV) INSERTION. REPORTER HAVE HAD THE CONCERN BROUGHT FORWARD BY MULTIPLE STAFF MEMBERS AND WAS ABLE TO OBSERVE AN INSERTION THIS MORNING WHERE SPONTANEOUS BLEEDING OCCURRED. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457141 ↗
• MalfunctionFeb 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN NEW IV SITE WAS FLUSHED, SALINE SPURTED OUT OF THE SIDE OF THE CANNULA AT THE TIP OF THE HUB. THE EVENT OCCURRED IN THE HOSPITAL WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236061 ↗
• MalfunctionDec 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE CATHETER WAS FLUSHED WITH SALINE, THE SALINE CAME OUT WHERE CATHETER MEETS HUB. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. THERE WAS MEDICAL INTERVENTION-IV REMOVAL AND RESTART. OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905589 ↗
• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE CATHETER WAS FLUSHED WITH SALINE, THE SALINE CAME OUT WHERE CATHETER MEETS HUB. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. THERE WAS MEDICAL INTERVENTION-IV REMOVAL AND RESTART. OUTCOME OF THE EVENT WAS RESOLVED. AGE OF THE PATIENT IS 64 YEARS OLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23517740 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKED FROM THE CATHETER HUB THROUGH AND DROPLETS OF BLOOD LEAKED FROM THE CATHETER CARTRIDGE IMMEDIATELY UPON USE. THE EVENT OCCURRED IN A HOSPITAL AND WAS MANAGED BY A HEALTHCARE PROFESSIONAL. THERE WAS NO PATIENT INJURY OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347243 ↗
• MalfunctionOct 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BLOOD IS LEAKING FROM THE CATHETER HUB AND CARTRIDGE AT TIMES. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT WAS HARM. OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23341450 ↗
• MalfunctionOct 20, 2025Break; Break

  IT WAS REPORTED THAT DURING DISCONTINUATION OF THE INTRAVENOUS FROM THE PATIENT, THE CATHETER TIP WAS NOT INTACT. ULTRASOUND OF THE RIGHT UPPER EXTREMITY SHOWED RIGHT ANTECUBITAL FOSSA, WITH A TUBULAR STRUCTURE WITHIN THE VESSEL THAT MEASURED 2.2 CM IN LENGTH. THERE WAS UNKNOWN PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335759 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE VALVE WAS NOT WORKING ON AND WAS LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932678 ↗
• MalfunctionSep 2, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE VALVE WAS NOT WORKING ON AND WAS LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932594 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT THE CATHETER TIP BROKE OFF INSIDE THE PATIENT. THERE WAS NO PATIENT HARM NOTED OR DOCUMENTED. THE OUTCOME WAS RESOLVED BY THE PATIENT BEING DISCHARGED FROM THE MEDICAL CENTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714871 ↗
• MalfunctionSep 30, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT IV CATHELONS WITHOUT WINGS WERE NOT SHOWING FLASHBACK. THE CATHELON WAS REMOVED AND ALSO HAD SIGNIFICANT BLOOD RETURN FROM THE POKE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334544 ↗
• MalfunctionSep 5, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETERS WERE BENT DURING INSERTION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20151995 ↗
• MalfunctionSep 4, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE CATHETERS WERE BENT DURING INSERTION. THERE WERE THREE DIFFERENT PATIENTS THAT WERE INVOLVED FOR EACH EVENT DATE (B)(6). THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20138611 ↗
• MalfunctionJul 1, 2024Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT THE CATHETER DID NOT DEPLOY THE SAFETY MECHANISM. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19650128 ↗
• MalfunctionJun 24, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE IV WAS DISLODGED FROM SITE, THE CANNULA WAS NOT INTACT, WITH MOST OF THE CLEAR CANNULA MISSING, AND A SMALL BEND WAS NOTICED IN THE REMAINING CANNULA ATTACHED TO THE IV HUB. LEFT ELBOW X-RAY ORDERED. THERE WAS A COMPLETELY OCCLUSIVE THROMBUS INVOLVING THE CEPHALIC VEIN AT THE LEVEL OF ANTECUBITAL FOSSA EXTENDING OVER A LENGTH OF APPROXIMATELY 9.6 CM (INCLUDING 2 TO 3 CM PROXIMAL TO THE ANTECUBITAL FOSSA). LINEAR ECHOGENIC AREA WITHIN THE CEPHALIC VEIN AT THIS LEVEL COULD REPRESENT LINEAR FLOATING THROMBUS OR FRAGMENT OF CANNULA. THERAPEUTIC ANTICOAGULATION AND DOAC AT DISCHARGE WERE PERFORMED, WITH A PLAN FOR A FOLLOW UP WITH THE DOCTOR AND A REPEAT U/S TO BE DONE.

  Patient problems: Insufficient Information

  MAUDE report 19593673 ↗
• MalfunctionMay 13, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE NEEDLE DID NOT FULLY RETRACT INTO THE SAFETY AND THE VALVE DIDN'T WORK. THIS OCCURRED WITH 2 DEVICES DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19304087 ↗
• MalfunctionAug 2, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CUSTOMER HAS NOTICED THAT THERE HAVE BEEN ISSUES WITH ADVANCING THE CATHLON. IT IS LIKE YOU HAVE TO ADVANCE THE NEEDLE FURTHER INTO THE VEIN TO ADVANCE THE CATHLON OR IT WILL NOT ADVANCE. IT FEELS LIKE SOME OF THE CATHLON IS STICKING. THE CUSTOMER EXPERIENCES FLASHBACK AND CAN NOT ADVANCE OR IT BLOWS THE VEIN AS YOU HAVE TO INSERT THE NEEDLE FURTHER THAN NORMAL. MINOR INJURY TO PATIENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17443505 ↗

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,