Jelco 3067Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10351688071217), received between Jan 9, 2018 and Apr 8, 2026 — classified as 5 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (11 reports).

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 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE INTRAVENOUS (IV) CATHETER LEAKED BLOOD WHEN IT WAS INSERTED. IT IS NOT SUPPOSED TO LET ANY BLOOD OUT. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817635 ↗
• MalfunctionAug 15, 2025Activation, Positioning or Separation Problem

  VEIN ACCESSED DURING IV PLACEMENT BUT NO FLASH OF BLOOD IN THE CHAMBER TO INDICATE IN THE VEIN. BLOOD IN CATHETER WHEN NEEDLE RETRACTED INDICATING BLOOD IN THE VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814191 ↗
• MalfunctionOct 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CATHETER LEAKING BLOOD AS THEY ADVANCED THE CATHETER FROM JUST BELOW WHERE IT ATTACHES TO THE HUB. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419935 ↗
• MalfunctionSep 18, 2024Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE SAFETY MECHANISM FAILED AFTER ENGAGED. IT POPPED OPEN WHEN PLACING THE DIRTY NEEDLE IN THE SHARPS BIN CAUSING A NEEDLESTICK. THE SAFETY MECHANISM OF THE DEVICE FAILED AFTER THE PROCEDURE AND WHEN THEY WERE ABOUT TO DISPOSE THE NEEDLE. THERE WAS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20248378 ↗
• MalfunctionAug 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PATIENT WAS ON AN IV THE CATHETER WAS LEAKING UNDER THE SKIN AT THE HUB. SHE WAS FORCED TO REMOVE THIS IV AND START ANOTHER ONE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967606 ↗
• MalfunctionJul 16, 2024Dull, Blunt; Connection Problem; Dull, Blunt; Connection Problem

  IT WAS REPORTED THAT WHEN ATTEMPTING TO PLACE THE IV, THE NEEDLE WAS DISCONNECTING FROM THE HUB, CAUSING FAILED IV ATTEMPTS. THE NEEDLES LOOKED DULL AND DIFFICULT TO PUNCTURE THROUGH THE SKIN CAUSING A DELAY OF THERAPY. THERE WERE NO MEDICATIONS BEING ADMINISTERED ALONGSIDE THE USE OF THE PRODUCT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARD OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752302 ↗
• MalfunctionJul 2, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BLOOD WAS LEAKING FROM WHERE IV IS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661647 ↗
• InjuryFeb 23, 2024

  THE ANGIOCATH HUB WITH TUBING WAS INSERTED IN THE ANTECUBITAL VEIN OF THE PATIENT. THE AREA WHERE THE HUB AND TUBING MEET HAD AN EVENT WHERE THE TUBING BROKE AND WAS RETAINED IN THE PATIENT REQUIRING REMOVAL OF A FOREIGN OBJECT PROCEDURE. THE TUBING WAS REMOVED SUCCESSFUL BY THE PHYSICIAN WITH NO PERMANENT HARM TO THE PATIENT. THE ATTACHED PICTURES ARE OF A NEW CATHETER AND PACKAGING. THE PATIENT'S CATHETER AND RETRIEVED TUBING HAS BEEN SEQUESTERED PER OUR POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18788309 ↗
• MalfunctionJan 24, 2024

  AFTER STARTING AN IV ON PATIENT, WENT TO DISPOSE OF THE SHARPS. IV CATHETER NEEDLE DID NOT FULLY RETRACT AND LOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571474 ↗
• MalfunctionOct 31, 2023

  SAFETY MECHANISM WOULD NOT ENGAGE AFTER SUCCESSFUL PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18038778 ↗
• MalfunctionAug 22, 2023

  PERIPHERAL IV CATHETER WITH EXCELLENT BLOOD RETURN. NEEDLE CAUGHT IN CATHETER WHILE ATTEMPTING TO WITHDRAW NEEDLE. ACCESS NOT OBTAINED. REQUIRED ADDITIONAL CATHETER AND ACCESS GAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594979 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Mechanical Problem

  INJURY WIT WAS REPORTED THAT THE PLASTIC BENT ON THE END AFTER THE NEEDLE WAS RETRACTED. NO PATIENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17261465 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PLASTIC BENT ON THE END AFTER THE NEEDLE WAS RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260094 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PLASTIC BENT ON THE END AFTER THE NEEDLE WAS RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259606 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PLASTIC BENT ON THE END AFTER THE NEEDLE WAS RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258953 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PLASTIC BENT ON THE END AFTER THE NEEDLE WAS RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17258798 ↗
• MalfunctionJul 5, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED, THAT THE PLASTIC BENT ON THE END, AFTER THE NEEDLE WAS RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17257775 ↗
• MalfunctionJun 30, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A BOX OF DEVICE UNITS (200 EACH) WAS RECEIVED WITH MISSING PRODUCT LABEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243857 ↗
• MalfunctionSep 10, 2022Material Fragmentation; Material Twisted/Bent; Material Fragmentation; Material Twisted/Bent

  IT WAS REPORTED THAT THE PLASTIC BENT ON THE END AFTER THE NEEDLE WAS RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397528 ↗
• MalfunctionAug 26, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WERE ISSUES WITH TRYING TO THREAD THE CATHETER OFF THE STYLET AND IT WOULD NOT RETRACT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15301161 ↗
• MalfunctionAug 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE, THE SAFETY FEATURE BUTTON THAT RETRACTS THE INTRAVENOUS (IV) NEEDLE FROM THE CATHETER FAILED. FURTHER INFORMATION INDICATED THAT THE PLASTIC CATHETER WOULD NOT SLIDE OFF THE NEEDLE USING THE GUIDE, WHICH RESULTED IN THE NURSE HAVING TO PULL THE NEEDLE OUT OF THE CATHETER WITHOUT THE NEEDLE BEING RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15293627 ↗
• MalfunctionAug 25, 2022Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  IT WAS REPORTED THAT DURING USE, THE SAFETY FEATURE BUTTON THAT RETRACTS THE INTRAVENOUS (IV) NEEDLE FROM THE CATHETER FAILED. FURTHER INFORMATION INDICATED THAT THE PLASTIC CATHETER WOULD NOT SLIDE OFF THE NEEDLE USING THE GUIDE, WHICH RESULTED IN THE NURSE HAVING TO PULL THE NEEDLE OUT OF THE CATHETER WITHOUT THE NEEDLE BEING RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292437 ↗
• MalfunctionAug 25, 2022Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  IT WAS REPORTED THAT DURING USE, THE SAFETY FEATURE BUTTON THAT RETRACTS THE INTRAVENOUS (IV) NEEDLE FROM THE CATHETER FAILED. FURTHER INFORMATION INDICATED THAT THE PLASTIC CATHETER WOULD NOT SLIDE OFF THE NEEDLE USING THE GUIDE, WHICH RESULTED IN THE NURSE HAVING TO PULL THE NEEDLE OUT OF THE CATHETER WITHOUT THE NEEDLE BEING RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292429 ↗
• MalfunctionAug 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE, THE SAFETY FEATURE BUTTON THAT RETRACTS THE INTRAVENOUS (IV) NEEDLE FROM THE CATHETER FAILED. FURTHER INFORMATION INDICATED THAT THE PLASTIC CATHETER WOULD NOT SLIDE OFF THE NEEDLE USING THE GUIDE, WHICH RESULTED IN THE NURSE HAVING TO PULL THE NEEDLE OUT OF THE CATHETER WITHOUT THE NEEDLE BEING RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292386 ↗
• MalfunctionAug 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING USE, THE SAFETY FEATURE BUTTON THAT RETRACTS THE INTRAVENOUS (IV) NEEDLE FROM THE CATHETER FAILED. FURTHER INFORMATION INDICATED THAT THE PLASTIC CATHETER WOULD NOT SLIDE OFF THE NEEDLE USING THE GUIDE, WHICH RESULTED IN THE NURSE HAVING TO PULL THE NEEDLE OUT OF THE CATHETER WITHOUT THE NEEDLE BEING RETRACTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15292385 ↗