Jelco 3260Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 15019517078398), received between Jul 21, 2017 and Sep 30, 2026 — classified as 5 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (25 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 93 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953337 ↗
• MalfunctionSep 24, 2026Fluid/Blood Leak

  It was reported that catheter advancement was more resistant than expected during insertion. In addition, blood was observed pooling at the end of the blue hub or fully bleeding from the hub, indicating that the blood control valve did not function as intended. There was patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883393 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  It was reported that during insertion of the Jelco ViaValve Safety IV Catheter, blood was observed oozing from the needle guard upon placement of the peripheral intravenous (PIV) catheter. There was patient involvement with no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50873277 ↗
• MalfunctionAug 27, 2026Fluid/Blood Leak

  It was reported that during IV catheter insertion, after the needle was inserted and the catheter advanced, blood continued to flow into the flashback chamber, along the sides of the device, and into the needle hub. Following successful IV insertion with positive flashback, the IV device was removed from the catheter; however, blood continued to flow from the catheter in the patient's extremity, indicating that the blood control feature may not have functioned as intended. The issue was observed by using IV catheters from the same box. A catheter from a different box (different lot number) was subsequently used, and the blood control feature functioned as expected, with no blood flow observed from the catheter after removal of the IV device and without distal pressure applied. There was patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479693 ↗
• MalfunctionAug 25, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439280 ↗
• InjuryMay 25, 2026Break

  IT WAS REPORTED THAT DURING IV REMOVAL IN THE POST-ANESTHESIA CARE UNIT; A PORTION OF THE PLASTIC IV CATHETER BROKE OFF AND REMAINED IN THE PATIENT. THE PATIENT WAS REFERRED TO THE EMERGENCY DEPARTMENT FOR EVALUATION, WHERE IMAGING DID NOT IDENTIFY A RETAINED FOREIGN OBJECT, AND WAS SUBSEQUENTLY REFERRED TO A VASCULAR SURGEON FOR FURTHER ASSESSMENT. THERE WAS PATIENT INVOLVEMENT AND REPORTED HARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 25272360 ↗
• MalfunctionApr 23, 2026

  ATTEMPTED PERIPHERAL IV CATHETER PLACEMENT WITH #22GAUGE ICU MEDICAL CATHETER, IV UNSUCCESSFUL, SAFETY MECHANISM DID NOT ACTIVATE LEAVING NEEDLE EXPOSED. NO INJURY TO PATIENT OR STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965200 ↗
• MalfunctionApr 15, 2026Retraction Problem

  IT WAS REPORTED THAT THE IV WAS INSERTED USING PROPER TECHNIQUE BUT DID NOT FULLY RETRACT. THE NEEDLE SLID OUT OF THE SAFETY CHAMBER. THE DEVICE WAS NOT PUSHED UNTIL IT CLICKED BEFORE BEING DISCONNECTED FROM THE PATIENT, WHICH RESULTED IN A NEEDLESTICK INJURY TO THE CLINICIAN. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889077 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE 22G IV CATHETERS FROM THE LOT NUMBER HAVE FAULTY BLOOD VIAVALVE. THERE WAS PATIENT INVOLVEMENT BUT, NO PATIENT HARM. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967077 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER INSERTION OF IV, THE NURSING NOTICED LEAKAGE AROUND INSERTION SITE. UPON CLOSER INSPECTION A SMALL "HOLE" OR "CRACK" WAS NOTICED IN THE CANNULA RIGHT BY THE HUB ON THE IV. THE IV WAS REMOVED AND REPLACED. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23878625 ↗
• MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE STARTING A PERIPHERAL IV, THE WRITER NOTICED BLOOD LEAKING FROM THE HUB AFTER THE NEEDLE WAS SECURED IN THE CHAMBER. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554868 ↗
• MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE STARTING A PERIPHERAL IV, THE WRITER NOTICED BLOOD LEAKING FROM THE HUB AFTER THE NEEDLE WAS SECURED IN THE CHAMBER. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23554849 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER THE NEEDLE GUARD IS REMOVED, THE VALVE CONTINUES TO LEAK BLOOD. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM. THE EVENT OCCURRED UPON REMOVING THE NEEDLE FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353845 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER HUB LEAKED BLOOD AFTER THE NEEDLE GUARD WAS REMOVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874082 ↗
• MalfunctionJul 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE LEAKING WHERE THE CATHLON MEETS THE BLUE HUB OF THE IVC. THE REPORTER STATED THE DEVICE WAS REMOVED FROM THE PATIENT AND ENSURED THE CATHETER TIP WAS STILL INTACT. THEY HAD TO RE-INSERT NEW IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569987 ↗
• MalfunctionJul 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT CORRECTLY. THE BLOOD ALSO ENTERED THE TOP OF DEVICE WHERE IT SHOULD NOT BE, AND BLOOD WAS LEAKING AT THE CONNECTION CHAMBER AND HUB. THE EVENT OCCURRED MULTIPLE TIMES WHILE IN USE WITH A PATIENT, AND THERE WERE UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22441331 ↗
• MalfunctionJul 1, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PLACING IN A PATIENT, IT STARTED TO LEAK BETWEEN THE PLASTIC CATHETER THAT STAYS IN THE PATIENT AND THE BLUE PORTION THAT INSERTS INTO THE EXTENSION TUBING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378220 ↗
• MalfunctionJun 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE BACK FLOW VALVE WAS NOT WORKING CAUSING THE BLOOD TO FLOW OUT WHEN THE NEEDLE WAS REMOVED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT OR CLINICIAN INJURY REPORTED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. RELATED LOT WAS DOCUMENTED ON (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125968 ↗
• MalfunctionMay 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE SEEMED TO HAVE A DEFECT WHERE THE CATHETER MEETS WITH THE HUB AS IF IT WASN'T SEALED APPROPRIATELY. AS A RESULT, BLOOD WAS SEEPING OUT AFTER THE IV HAS BEEN INSERTED. THERE WAS PATIENT INVOLVEMENT, BUT THE PATIENT WAS NOT HARMED OR INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081934 ↗
• MalfunctionDec 12, 2024Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT A REGISTERED NURSE INSERTED A 22G IV INTO THE PATIENT'S RIGHT FOREARM. WHEN REGISTERED NURSE WAS GOING TO PUT A TEGADERM OVER THE SITE, THE PATIENT WAS NOTED TO HAVE BEEN BLEEDING FROM SITE, AND IT WASN'T STOPPING. THE REGISTERED NURSE THEN ATTEMPTED TO FLUSH THE IV AND NOTICED THAT WHILE FLUSHING, LIQUID WAS COMING OUT FROM A HOLE IN THE CATHETER NEAR THE IV HUB. THE REGISTERED NURSE REMOVED THE IV FROM PATIENT'S RIGHT ARM AND APPLIED PRESSURE TO SITE. GAUZE DRESSING AND TAPE WERE APPLIED TO THE PATIENT'S RIGHT FOREARM. THE EVENT OCCURRED AT THE HOSPITAL. THE ORIGINAL INTENDED PROCEDURE WAS PERIPHERAL INTRAVENOUS ACCESS. DELAY OF THERAPY WAS UNKNOWN. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914055 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO OF THE 22G CATHETERS WERE LEAKING AT THE POINT WHERE THE CATHETER PART THAT GOES INTO THE PATIENT ATTACHES TO THE HUB. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20871914 ↗
• MalfunctionNov 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE STARTING A PERIPHERAL IV, THE WRITER NOTICED BLOOD LEAKING FROM THE HUB AFTER THE NEEDLE WAS SECURED IN THE CHAMBER. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724849 ↗
• MalfunctionAug 20, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE NURSE STARTED AN IV ON A PATIENT AND THE JELCO CATHETER MALFUNCTIONED. SHE DID PULL BACK ON THE CATHETER TO RETRACT THE NEEDLE, BUT WHEN SHE DISCONNECTED THE NEEDLE/PROTECTER FROM THE HUB, THE NEEDLE WAS STILL SITTING INSIDE THE CATHETER/HUB. SHE HAD TO GRAB THE NEEDLE AND REMOVE IT FROM HER FINGERS. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20003468 ↗
• MalfunctionJun 24, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE IV CATHETER WAS NOT FLOWING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601052 ↗
• MalfunctionJun 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHILE ADVANCING CATHLON AND WITHDRAWING NEEDLE, CATHLON BENT AT HUB. VALVE DID NOT WORK, REMOVED NEEDLE AND BLOOD CAME OUT. THERE WAS NO INJURY SUSTAINED AS CATHLON REMOVED WHEN BENDING WAS NOTED. THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AND IS NOT RETURNING. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566990 ↗

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,