Jelco 3080Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 10351688071330), received between Aug 28, 2017 and Mar 30, 2026 — classified as 2 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER DETACHED SPONTANEOUSLY AT THE CATHLON LEVEL PRIOR TO THE REMOVAL PROCEDURE. THIS RESULTS IN BLOOD LEAKAGE AND ENVIRONMENTAL CONTAMINATION, REQUIRING BOTH PATIENT REASSURANCE AND IMMEDIATE CLEANING. MULTIPLE BATCHES APPEAR TO BE AFFECTED. THESE INCIDENTS HAVE BEEN REPORTED BY THE IMAGING DEPARTMENTS, MRI, X-RAY, CT SCAN, AND NUCLEAR MEDICINE AND INVOLVED FOUR ITEMS, IN TOTAL, ONE FOR EACH ROOM AND ON EACH DIFFERENT PATIENT CONCERNED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734483 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER DETACHED SPONTANEOUSLY AT THE CATHLON LEVEL PRIOR TO THE REMOVAL PROCEDURE. THIS RESULTS IN BLOOD LEAKAGE AND ENVIRONMENTAL CONTAMINATION, REQUIRING BOTH PATIENT REASSURANCE AND IMMEDIATE CLEANING. MULTIPLE BATCHES APPEAR TO BE AFFECTED. THESE INCIDENTS HAVE BEEN REPORTED BY THE IMAGING DEPARTMENTS, MRI, X-RAY, CT SCAN, AND NUCLEAR MEDICINE AND INVOLVED FOUR ITEMS, IN TOTAL, ONE FOR EACH ROOM AND ON EACH DIFFERENT PATIENT CONCERNED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734343 ↗
• MalfunctionMar 19, 2026Environmental Particulates

  IT WAS FURTHER REPORTED THAT THE CATHETER HAD BURRS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641070 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Sharp Edges; Fluid/Blood Leak; Sharp Edges

  IT WAS REPORTED THAT THE PRODUCT DETACHED FROM THE SHARP HUB WHEN THE CATHETER WAS ADVANCED AND THE SHARP WAS RETRACTED. WHEN THIS HAPPENED, THE CATHETER FREE FLOWED WITH BLOOD RETURN AND CREATED A SAFETY RISK WITH LOTS OF BLOOD ON THE PATIENT/STRETCHER, ETC. THE FACILITY HAD MULTIPLE STAFF MEMBERS WHO ENCOUNTERED THE SAME SITUATION. SAMPLE IS NOT AVAILABLE FOR RETURN. THERE WERE PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574138 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AS SOON AS THE IV CATHETER WAS INSERTED THE BOTTOM ATTACHMENT TO IV CATHETER FELL OUT BY ITSELF, BLOOD LEAKED EVERYWHERE FROM ANTECUBITAL AREA TODAY, PATIENT CLOTHING AND BEDDING HAD TO BE CHANGED. PER REPORTER ANOTHER STAFF COMPLAINED ABOUT THIS PROBLEM TOO. THE REPORTER NOTED THAT THESE CATHETERS HAVE WINGS, VERSUS THE OLD IV NUMBER 22 THAT HAD NO WINGS AND HAD NO PROBLEMS. ON ANOTHER OCCASION, A RELATIVE OBSERVED THIS LEAKAGE OF BLOOD WHEN THE BOTTOM FELL OUT AS REPORTED EARLIER. THERE WAS A RISK TO HEALTH CARE STAFF AS THERE WAS AN EXPOSURE TO BLOOD. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545940 ↗
• MalfunctionJul 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AS SOON AS THE IV CATHETER WAS INSERTED THE BOTTOM ATTACHMENT TO IV CATHETER FELL OUT BY ITSELF, BLOOD LEAKED EVERYWHERE FROM ANTECUBITAL AREA TODAY, PATIENT CLOTHING AND BEDDING HAD TO BE CHANGED. PER REPORTER ANOTHER STAFF COMPLAINED ABOUT THIS PROBLEM TOO. THE REPORTER NOTED THAT THESE CATHETERS HAVE WINGS, VERSUS THE OLD IV NUMBER 22 THAT HAD NO WINGS AND HAD NO PROBLEMS. ON ANOTHER OCCASION, A RELATIVE OBSERVED THIS LEAKAGE OF BLOOD WHEN THE BOTTOM FELL OUT AS REPORTED EARLIER. THERE WAS A RISK TO HEALTH CARE STAFF AS THERE WAS AN EXPOSURE TO BLOOD. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22545939 ↗
• MalfunctionApr 22, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE CATHETER HUB WAS VERY LOOSE AND DETACHED EASILY. THE IV CATHETER WAS FALLING OFF THE NEEDLE JUST UPON REMOVING THE CAP. THE NEEDLE GUARD DID NOT SLIDE BACK WHEN PULLING BACK ON IT, RATHER IT DETACHED FROM THE CATHETER CAUSING THE BLOOD TO FLOW FREELY AND LEFT THE NEEDLE EXPOSED. SOMETIMES THIS HAPPENED SPONTANEOUSLY WITHOUT EVEN PULLING BACK ON THE NEEDLE GUARD. THIS HAD RESULTED IN ONE NEEDLE STICK INJURY. IV STARTED WITH A LOT OF DIFFICULTY AND WAS A SAFETY CONCERN. IT CAUSED AN INCREASED EXPOSURE TO BLOOD AND UNPROTECTED NEEDLES. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 21885698 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE NEEDLE ENTERED THE VEIN, BLOOD CAME OUT AT HUB PRIOR TO THREADING OF CATHETER. THE CLINICIAN REPORTED HEARING A "POP SOUND". THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139121 ↗
• MalfunctionSep 6, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED A DIFFICULTY IN PRICKING THE PATIENT AND GETTING INTO THE VEIN. THE CATHETER HANGS IN THE PATIENT'S VEIN AND IN SOME CASES, THEY FAILED TO INTRODUCE THE CATHETER TO THE PATIENT EVEN AFTER 4 ATTEMPTS. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157193 ↗
• MalfunctionSep 6, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED A DIFFICULTY IN PRICKING THE PATIENT AND GETTING INTO THE VEIN. THE CATHETER HANGS IN THE PATIENT'S VEIN AND IN SOME CASES, THEY FAILED TO INTRODUCE THE CATHETER TO THE PATIENT EVEN AFTER 4 ATTEMPTS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156907 ↗
• MalfunctionSep 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CATHETER LEAK WHEN THE NURSE STABBED PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126670 ↗
• MalfunctionDec 3, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE IV CATHETER SHEARED OFF OR MISSING. ATTEMPTED TO FLUSH IV SALINE LOCK WITH NS 10ML. UPON FLUSHING IV WAS NOT PATENT AND LEAKING SO REMOVED IV AND NOTICED THERE WAS NO LONG CLEAR CATHETER PIECE, IT HAD BROKEN OFF COMPLETELY AT THE HUB OF THE CATHETER. UNKNOWN HOW LONG IT HAD BEEN LIKE THAT. THE IV WAS STARTED NEW YESTERDAY BY ANOTHER COMMUNITY PARAMEDIC WITH NO COMPLICATIONS. THE PT. HAD BEEN KNOW TO PICK AND PULL AT HER IVS OVER THE REFERRAL. IT WAS A 22G IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929046 ↗
• MalfunctionDec 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE IV CATHETER SHEARED OFF OR MISSING. ATTEMPTED TO FLUSH IV SALINE LOCK WITH NS 10ML. UPON FLUSHING IV WAS NOT PATENT AND LEAKING SO REMOVED IV AND NOTICED THERE WAS NO LONG CLEAR CATHETER PIECE, IT HAD BROKEN OFF COMPLETELY AT THE HUB OF THE CATHETER. UNKNOWN HOW LONG IT HAD BEEN LIKE THAT. THE IV WAS STARTED NEW YESTERDAY BY ANOTHER COMMUNITY PARAMEDIC WITH NO COMPLICATIONS. THE PT. HAD BEEN KNOW TO PICK AND PULL AT HER IVS OVER THE REFERRAL. IT WAS A 22G IV.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12920565 ↗
• MalfunctionJun 23, 2021Dull, Blunt; Dull, Blunt

  DEVICE EVALUATION COMPETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049961 ↗
• MalfunctionJul 24, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CATHETER IS DULL. NO FURTHER INFORMATION PROVIDED. NO PATIENT INJURY RESULTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7716005 ↗
• MalfunctionJul 24, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL CATHETER IS DULL. NO FURTHER INFORMATION PROVIDED. NO PATIENT INJURY RESULTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715989 ↗
• MalfunctionJul 2, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656502 ↗
• MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652299 ↗
• MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652297 ↗
• MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652248 ↗
• MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652149 ↗
• MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652115 ↗
• MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652100 ↗
• MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652051 ↗
• MalfunctionJun 29, 2018Dull, Blunt; Dull, Blunt

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETER WAS DULL ON INSERTION. NO ADVERSE EFFECTS WERE EXPERIENCED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7652018 ↗