Jelco 3266Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 15019517078428), received between Aug 7, 2017 and May 15, 2026 — classified as 10 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (31 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 25 most recent of 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Fail-Safe Problem

  IT WAS REPORTED THAT PHYSICIAN INCURRED AN IV STICK INJURY DUE TO FAILED SAFETY COVER ACTIVATION AFTER USE. THE PHYSICIAN WAS PLACING AN IV IN THE PATIENT¿S L EXTERNAL JUGULAR. AFTER RECEIVING FLASH, THEY PULLED BACK TO RETRACT THE NEEDLE, HOWEVER, THE SAFETY PROTECTOR DID NOT ACTIVATE, AND THE PHYSICIAN INCURRED A NEEDLE STICK INJURY. THE EVENT OCCURRED AT THE HOSPITAL IN EMERGENCY DEPARTMENT. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25184059 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  IT WAS STATED THAT WHEN THE NURSE WAS INSERTING AN IV CATHETER INTO THE PATIENT¿S ARM, THEY ADVANCED THE CATHETER AS IS STANDARD PROCEDURE AND BLOOD BEGAN POURING OUT. THE VALVE INSIDE THAT SUPPOSED TO STOP THE BLOOD FROM COMING BACK OUT OF THE CATHETER FAILED. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162244 ↗
• MalfunctionMay 8, 2026Fluid/Blood Leak

  AN EVENT INVOLVING JELCO VIAVALVE SAFETY IV CATHETER REPORTED THAT DURING INTRAVENOUS ACCESS, VENOUS ENTRY WAS SUCCESSFULLY ACHIEVED; HOWEVER, THE CATHETER BEGAN LEAKING JUST BELOW THE HUB. THE INTRAVENOUS (IV) WAS DISCONTINUED DUE TO THE DEFECTIVE CATHETER, AND A NEW IV WAS INITIATED. THE REPLACEMENT CATHETER EXHIBITED THE SAME ISSUE, WITH LEAKAGE OCCURRING BELOW THE HUB. INSPECTION REVEALED A HOLE AT THE BASE OF THE HUB. AS A RESULT OF THIS INCIDENT, ADDITIONAL, UNANTICIPATED CARE AND TESTING WERE REQUIRED, ALONG WITH A PROLONGED PROCEDURE, NECESSITATING THREE IV CANNULATION ATTEMPTS DUE TO FAULTY EQUIPMENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129418 ↗
• MalfunctionApr 23, 2026

  RN REPORTED THAT THE IV CATHETER WAS HARD TO USE AND DID NOT GIVE A FLASH BACK WHEN THREADING THE CATHETER, REQUIRED AN ULTRASOUND TO GUIDE THE CATHETER WITHOUT BLOWING THE PATIENT'S VEIN. PER ED NURSING LEADERSHIP, THIS IS A REOCCURRING ISSUE WITH THE NEW ICU MEDICAL CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965535 ↗
• MalfunctionApr 23, 2026

  RN ATTEMPTED TO PLACED IV IN PATIENT'S FOREARM, BUT WAS UNABLE TO REDIRECT THE NEEDLE WITHOUT BLOWING VEIN WITH NEW IV CATHETERS. THIS RESULTED IN THE PATIENT BEING POKED MULTIPLE TIMES FOR A SUCCESSFUL IV ACCESS. PER RN, THE COMPANY REPRESENTATIVE STATES THE CATHETERS ARE TOO SHARP AND ARE UNABLE TO BE REDIRECTED LIKE OUR OLD CATHETERS. PER STAFF AND NURSING LEADERS, MULTIPLE STAFF INCLUDING EXPERIENCED RNS WITH >20 YEARS OF BEDSIDE EXPERIENCE ARE REPORTING CONCERNS THAT THEY HAVE NEVER HAD SUCH DIFFICULTIES REQUIRING MULTIPLE ATTEMPTS FOR IV ACCESS WITH ANY OTHER BRAND OF IV CATHETERS IN THEIR CAREER. MULTIPLE RNS AND PATIENTS HAVE REPORTED SAFETY CONCERNS WITH THIS NEW BRAND OF IV CATHETERS.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24965431 ↗
• MalfunctionApr 23, 2026

  PATIENT REPORTED A COMPLAINT "THEY HAD A HARD TIME GETTING THE IV IN. VERY PAINFUL. THE VEINS WOULD BLOW AND TUBE BENT."

  Patient problems: Pain; Rupture

  MAUDE report 24965429 ↗
• MalfunctionApr 23, 2026

  ONGOING DIFFICULTY WITH ICU MEDICAL/"JELCO" BRAND PERIPHERAL INTRAVENOUS CATHETERS, POOR BLOOD RETURN/"FLASHBACK", PATIENT COMPLAINT OF PAIN AT SITE, MULTIPLE ATTEMPTS TO START IV, REQUIRES 2 HANDS FOR INSERTION. THIS IS THE CENTRAL THEME WE ARE TRACKING AND TRENDING FOR [REDACTED] HOSPITAL WITH APPROXIMATELY 50 EVENTS REPORTED BY VARIOUS EXPERIENCED NURSES ACROSS MULTIPLE DEPARTMENTS (ER, MED/SURG, L&D [LABOR AND DELIVERY], ATU [ADMISSION TRANSFER UNIT]).

  Patient problems: Needle Stick/Puncture; Pain

  MAUDE report 24965203 ↗
• MalfunctionApr 22, 2026

  WHEN THE NURSE WAS INSERTING AN IV CATHETER INTO THE PATIENTS ARM, SHE ADVANCED THE CATHETER AS IS STANDARD PROCEDURE AND BLOOD BEGAN POURING OUT. THE VALVE INSIDE THAT IS SUPPOSED TO STOP THE BLOOD FROM COMING BACK OUT OF THE CATHETER FAILED. THE CATHETER WAS REMOVED AND THE PROCEDURE HAD TO BE REDONE WITH ANOTHER CATHETER WITH A PROPERLY FUNCTIONING VALVE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24953013 ↗
• InjuryApr 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE OF THEIR PARAMEDICS STARTED A VIAVALVE SAFETY IV CATHETER 20G IV. THEY GOT GOOD PLACEMENT, BUT WHEN THEY WENT TO ATTACHED AN EXTENSION TO THE CATHETER, THE CATHETER DETACHED AT THE PINK HUB. LEAVING THE FLEXIBLE CATHETER INSIDE THE PATIENT WITH NO WAY TO GET IT OUT. NO SIGNIFICANT DELAY, IV UNABLE TO BE ESTABLISHED WHEN PATIENT REQUIRED ONE. HOSPITAL HAD TO REMOVE THE CATHETER THAT WAS LEFT INSERTED IN THE PATIENT. IV WAS BEING STARTED, NO MEDICATION WAS BEING GIVEN. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS A PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839361 ↗
• MalfunctionMar 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN RETRACTING THE NEEDLE, THE SLIDE GRIP STOPPED BEFORE THE EXPECTED CLICK AND FELT OBSTRUCTED, POSSIBLY DUE TO DEBRIS. AS A RESULT, APPROXIMATELY 0.25 TO 0.5 INCHES OF THE NEEDLE REMAINED EXPOSED. IT WAS ALSO NOTED THAT THE CATHETER¿S SELF-OCCLUDING FEATURE DID NOT FUNCTION AS EFFECTIVELY AS EXPECTED AND ALLOWED A SLOW FLOW OF BLOOD. THE EVENT OCCURRED DURING CATHETER INSERTION AT ACADIAN AMBULANCE. NO MEDICATION WAS USED WITH THE PRODUCT, AND THE DEVICE HAD NOT BEEN REPROCESSED OR RE-STERILIZED PRIOR TO USE. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO DELAY IN THERAPY, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611507 ↗
• InjuryMar 4, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A PLASTIC IV CATHETER BROKE OFF INSIDE THE PATIENT¿S VEIN DURING INFUSION. THE NEEDLE WAS NEW AND WITHIN ITS EXPIRATION DATE. EMS PERSONNEL WERE INFORMED UPON ARRIVAL THAT THE IV SITE WAS LEAKING AND SUSPECTED THE CANNULA HAD BEEN PROBLEMATIC. ATTEMPTS TO STOP THE LEAK AND ASSESS THE IV SHOWED BLOOD RETURN AND LEAKAGE, BUT NO INFILTRATION OR BLOWN VEIN. WHEN THE LINE WAS REMOVED, THE CATHETER WAS MISSING AND COULD NOT BE RETRIEVED DUE TO BLOOD OBSTRUCTING VISIBILITY. THE PATIENT WAS TRANSPORTED TO CORVALLIS HOSPITAL FOR MEDICAL INTERVENTION, INCLUDING SURGICAL REMOVAL OF THE CATHETER. THE INCIDENT OCCURRED WHILE THE PATIENT WAS STATIONARY ON THE COT IN A NON-MOVING AMBULANCE. THE PATIENT¿S CARE WAS DISRUPTED, MEDICAL INTERVENTION WAS REQUIRED, AND THE INCIDENT POSED A SAFETY THREAT. NO FOLLOW-UP INFORMATION ON THE OUTCOME OR REPORTED HARM IS AVAILABLE.

  Patient problems: Foreign Body In Patient; Needle Stick/Puncture

  MAUDE report 24507637 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INSERTION THERE WAS SIGNIFICANT BLOOD LEAKING FROM THE CATHETER ONCE THE NEEDLE WAS RETRACTED AND REMOVED FROM THE CATHETER. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT, AND THERE WAS NO HARM OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283518 ↗
• MalfunctionFeb 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INSERTION, THERE WAS SIGNIFICANT BLOOD LEAKING FROM THE CATHETER ONCE THE NEEDLE WAS RETRACTED AND REMOVED FROM THE CATHETER. THE EVENT OCCURRED WHILE IN USE WITH PATIENT, AND THERE WAS NO HARM OR MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283294 ↗
• MalfunctionFeb 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INSERTION OF THE VIAVALVE IV CATHETERS, THERE WAS SIGNIFICANT BLOOD LEAKING FROM THE CATHETER ONCE THE NEEDLE WAS RETRACTED AND REMOVED FROM THE CATHETER. THE EVENT OCCURRED WHILE IN USE WITH PATIENT PREOP CHAMPAIGN SURGERY CENTER. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270434 ↗
• MalfunctionFeb 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING INSERTION OF THE VIAVALVE IV CATHETERS, THERE WAS SIGNIFICANT BLOOD LEAKING FROM THE CATHETER ONCE THE NEEDLE WAS RETRACTED AND REMOVED FROM THE CATHETER. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PREOP CHAMPAIGN SURGERY CENTER. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270315 ↗
• MalfunctionFeb 4, 2026Separation Problem

  IT WAS REPORTED THAT THE CATHETER CAME APART AND LEAVING THE PLASTIC CANNULA IN THE PATIENT. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258379 ↗
• MalfunctionFeb 4, 2026Separation Problem

  IT WAS REPORTED THAT THE CATHETER CAME APART AND LEAVING THE PLASTIC CANNULA IN THE PATIENT. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258326 ↗
• MalfunctionJan 21, 2026Fluid/Blood Leak

  IT WAS STATED THAT AN IV CATHETER WAS INSERTED, BUT THE VALVE DID NOT STOP THE BLOOD FROM FLOWING BACK. PER REPORTED, THERE WAS A PATIENT INVOLVEMENT AND NO HARM REPORTED. EVALUATION OF THE DEVICE COULD NOT BE PERFORMED DUE TO THE DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136254 ↗
• MalfunctionJan 21, 2026Fluid/Blood Leak

  IT WAS STATED THAT AN IV CATHETER WAS INSERTED, BUT THE VALVE DID NOT STOP THE BLOOD FROM FLOWING BACK. PER REPORTED, THERE WAS A PATIENT INVOLVEMENT AND NO HARM REPORTED. EVALUATION OF THE DEVICE COULD NOT BE PERFORMED DUE TO THE DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136212 ↗
• MalfunctionJan 21, 2026Fluid/Blood Leak

  IT WAS STATED THAT AN IV CATHETER WAS INSERTED, BUT THE VALVE DID NOT STOP THE BLOOD FROM FLOWING BACK. PER REPORTED, THERE WAS A PATIENT INVOLVEMENT AND NO HARM REPORTED. EVALUATION OF THE DEVICE COULD NOT BE PERFORMED DUE TO THE DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24136153 ↗
• MalfunctionJan 21, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE IV CATHETER WAS INSERTED, THE VALVE DID NOT STOP THE BLOOD FROM FLOWING BACK. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133342 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT ANOTHER PATIENT HAD BLOOD BACKFLOW THROUGH THE IV CATHETER. THE VALVE FAILED ACCORDING TO THE IV PRODUCT INFORMATION. THIS WAS THE THIRD CATHETER. THERE WAS NO REPORTED PATIENT HARM. (B)(4) DOCUMENT THE 3RD CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968582 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN INTRAVENOUS (IV) CATHETER WAS INSERTED, BUT THE VALVE DID NOT STOP THE BLOOD FROM FLOWING BACK. THE VALVE FAILED. THE PATIENT BLED ALL OVER THE BED, WHICH SHOULD NOT HAVE HAPPENED. THIS WAS THE FOURTH CATHETER WHERE THIS ISSUE OCCURRED. THERE WAS NO REPORTED PATIENT HARM. (B)(6) DOCUMENT THE 3RD CATHETER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23959538 ↗
• InjuryJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE FAILED TO PREVENT BLOOD FROM FLOWING OUT OF THE CATHETER. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT. AN INTRAVENOUS (IV) WAS INSERTED AND BACKFLOW INTO THE CHAMBER WAS NOTED, WHEN DISCONNECTED TO HOOK TO FLUIDS, IT BEGAN TO BLEED. THERE WAS MEDICAL INTERVENTION REQUIRED, PRESSURE HELD AND IV TUBING CONNECTED. THE OUTCOME OF THE EVENT WAS RESOLVED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23959111 ↗
• InjuryDec 16, 2025Break; Break

  IT WAS REPORTED THAT THE CATHETER REMAINED IN THE VEIN AND WAS UNABLE TO BE RETRIEVED. THE PATIENT WAS IN THE EMERGENCY DEPARTMENT AND AT THE TIME OF DISCHARGE, THE NURSE WENT TO REMOVE THE INTRAVENOUS (IV) IN THE PATIENT'S LEFT AC, AND IT WOULD NOT COME OUT. MANY ATTEMPTS WERE MADE BY DIFFERENT NURSES WITHOUT SUCCESS AND WHEN A NURSE WAS ABLE TO REMOVE THE IV, ONLY THE PLASTIC HUB CAME OFF. THE PATIENT WAS SENT TO VASCULAR SURGERY FOR REMOVAL IN THE OPERATING ROOM (OR). THERE WAS NO HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821498 ↗

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,