Jelco 3060Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 10351688071187), received between Aug 7, 2017 and May 19, 2026 — classified as 7 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Fail-Safe Did Not Operate

  IT WAS REPORTED THAT WHEN THE NURSE STARTED THE IV THERE WAS NO ISSUES AND HEARD THE CLICK THAT SAFETY COVER WAS ENGAGED POST IV INSERTION OF USED NEEDLE. AFTER IV SECURED THE NURSE WENT TO PUT THE INSERTION NEEDLE INTO SHARPS BIN WHILE THEY FELT A POKE FROM THE USED NEEDLE. THE EVENT OCCURRED AFTER THE USE. THERE WERE NO PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: Needle Stick/Puncture

  MAUDE report 25222399 ↗
• MalfunctionMar 3, 2026Complete Blockage

  IT WAS REPORTED THAT A PHLEBITIS OCCURRED IN SEVERAL PATIENTS FOLLOWING THE INSERTION OF CATHETERS IN THE HOSPITAL, WITH THE ONSET OF SYMPTOMS FOR SOME PATIENTS APPEARING WITHIN 24 HOURS AFTER CATHETER PLACEMENT. THE PACKAGING IS INTACT AND NO VISIBLE DEFECT WAS OBSERVED. HOWEVER, DURING CATHETER INSERTION, THERE WAS NO BLOOD RETURN EVEN THOUGH THE DEVICE WAS CORRECTLY POSITIONED IN THE VEIN. SEVERAL CLINICAL SIGNS WERE REPORTED, INCLUDING EDEMA, PAIN, SIGNIFICANT REDNESS, AND IN ONE CASE A THROMBOSIS. THE AFFECTED INSERTION SITES WERE LOCATED ON THE UPPER LIMBS (LEFT AND RIGHT). THE NURSES PERFORMING THE INSERTIONS HAD DIFFERING LEVELS OF EXPERTISE, RANGING FROM BEGINNER TO EXPERT WITHIN THE CARE UNIT. THE PATIENT INITIALS ARE (B)(6), FEMALE, BORN ON (B)(6) 1996. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Erythema; Pain; Swelling/ Edema; Vasculitis

  MAUDE report 24500835 ↗
• MalfunctionMar 3, 2026Complete Blockage

  IT WAS REPORTED THAT A PHLEBITIS OCCURRED IN SEVERAL PATIENTS FOLLOWING THE INSERTION OF CATHETERS IN THE HOSPITAL, WITH THE ONSET OF SYMPTOMS FOR SOME PATIENTS APPEARING WITHIN 24 HOURS AFTER CATHETER PLACEMENT. THE PACKAGING IS INTACT AND NO VISIBLE DEFECT WAS OBSERVED. HOWEVER, DURING CATHETER INSERTION, THERE WAS NO BLOOD RETURN EVEN THOUGH THE DEVICE WAS CORRECTLY POSITIONED IN THE VEIN. SEVERAL CLINICAL SIGNS WERE REPORTED, INCLUDING EDEMA, PAIN, SIGNIFICANT REDNESS, AND IN ONE CASE A THROMBOSIS. THE AFFECTED INSERTION SITES WERE LOCATED ON THE UPPER LIMBS (LEFT AND RIGHT). THE NURSES PERFORMING THE INSERTIONS HAD DIFFERING LEVELS OF EXPERTISE, RANGING FROM BEGINNER TO EXPERT WITHIN THE CARE UNIT. THE PATIENT INITIALS ARE P. P., MALE, BORN ON 16-MAY-1963. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Erythema; Pain; Swelling/ Edema; Vasculitis

  MAUDE report 24500499 ↗
• MalfunctionMar 3, 2026Complete Blockage

  IT WAS REPORTED THAT A PHLEBITIS OCCURRED IN SEVERAL PATIENTS FOLLOWING THE INSERTION OF CATHETERS IN THE HOSPITAL, WITH THE ONSET OF SYMPTOMS FOR SOME PATIENTS APPEARING WITHIN 24 HOURS AFTER CATHETER PLACEMENT. THE PACKAGING IS INTACT AND NO VISIBLE DEFECT WAS OBSERVED. HOWEVER, DURING CATHETER INSERTION, THERE WAS NO BLOOD RETURN EVEN THOUGH THE DEVICE WAS CORRECTLY POSITIONED IN THE VEIN. SEVERAL CLINICAL SIGNS WERE REPORTED, INCLUDING EDEMA, PAIN, SIGNIFICANT REDNESS, AND IN ONE CASE A THROMBOSIS. THE AFFECTED INSERTION SITES WERE LOCATED ON THE UPPER LIMBS (LEFT AND RIGHT). THE NURSES PERFORMING THE INSERTIONS HAD DIFFERING LEVELS OF EXPERTISE, RANGING FROM BEGINNER TO EXPERT WITHIN THE CARE UNIT. THE PATIENT INITIALS ARE (B)(6)., FEMALE, BORN ON (B)(6) 1932. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Erythema; Pain; Swelling/ Edema; Vasculitis

  MAUDE report 24500455 ↗
• MalfunctionMar 3, 2026Complete Blockage

  IT WAS REPORTED THAT A PHLEBITIS OCCURRED IN SEVERAL PATIENTS FOLLOWING THE INSERTION OF CATHETERS IN THE HOSPITAL, WITH THE ONSET OF SYMPTOMS FOR SOME PATIENTS APPEARING WITHIN 24 HOURS AFTER CATHETER PLACEMENT. THE PACKAGING IS INTACT AND NO VISIBLE DEFECT WAS OBSERVED. HOWEVER, DURING CATHETER INSERTION, THERE WAS NO BLOOD RETURN EVEN THOUGH THE DEVICE WAS CORRECTLY POSITIONED IN THE VEIN. SEVERAL CLINICAL SIGNS WERE REPORTED, INCLUDING EDEMA, PAIN, SIGNIFICANT REDNESS, AND IN ONE CASE A THROMBOSIS. THE AFFECTED INSERTION SITES WERE LOCATED ON THE UPPER LIMBS (LEFT AND RIGHT). THE NURSES PERFORMING THE INSERTIONS HAD DIFFERING LEVELS OF EXPERTISE, RANGING FROM BEGINNER TO EXPERT WITHIN THE CARE UNIT. THE PATIENT INITIALS ARE (B)(6), FEMALE, BORN ON (B)(6) 1992. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Erythema; Pain; Swelling/ Edema; Vasculitis

  MAUDE report 24500442 ↗
• MalfunctionMar 3, 2026Complete Blockage

  IT WAS STATED THAT A PHLEBITIS OCCURRED IN SEVERAL PATIENTS FOLLOWING THE INSERTION OF CATHETERS IN THE HOSPITAL, WITH THE ONSET OF SYMPTOMS FOR SOME PATIENTS APPEARING WITHIN 24 HOURS AFTER CATHETER PLACEMENT. THE PACKAGING IS INTACT AND NO VISIBLE DEFECT WAS OBSERVED. HOWEVER, DURING CATHETER INSERTION, THERE WAS NO BLOOD RETURN EVEN THOUGH THE DEVICE WAS CORRECTLY POSITIONED IN THE VEIN. SEVERAL CLINICAL SIGNS WERE REPORTED, INCLUDING EDEMA, PAIN, SIGNIFICANT REDNESS, AND IN ONE CASE A THROMBOSIS. THE AFFECTED INSERTION SITES WERE LOCATED ON THE UPPER LIMBS (LEFT AND RIGHT). THE NURSES PERFORMING THE INSERTIONS HAD DIFFERING LEVELS OF EXPERTISE, RANGING FROM BEGINNER TO EXPERT WITHIN THE CARE UNIT. THE PATIENT INITIALS ARE (B)(6), MALE, BORN ON (B)(6) 1938.

  Patient problems: Erythema; Pain; Swelling/ Edema; Vasculitis

  MAUDE report 24500422 ↗
• MalfunctionMar 3, 2026Complete Blockage

  IT WAS REPORTED THAT A PHLEBITIS OCCURRED IN SEVERAL PATIENTS FOLLOWING THE INSERTION OF CATHETERS IN THE HOSPITAL, WITH THE ONSET OF SYMPTOMS FOR SOME PATIENTS APPEARING WITHIN 24 HOURS AFTER CATHETER PLACEMENT. THE PACKAGING IS INTACT AND NO VISIBLE DEFECT WAS OBSERVED. HOWEVER, DURING CATHETER INSERTION, THERE WAS NO BLOOD RETURN EVEN THOUGH THE DEVICE WAS CORRECTLY POSITIONED IN THE VEIN. SEVERAL CLINICAL SIGNS WERE REPORTED, INCLUDING EDEMA, PAIN, SIGNIFICANT REDNESS, AND IN ONE CASE A THROMBOSIS. THE AFFECTED INSERTION SITES WERE LOCATED ON THE UPPER LIMBS (LEFT AND RIGHT). THE NURSES PERFORMING THE INSERTIONS HAD DIFFERING LEVELS OF EXPERTISE, RANGING FROM BEGINNER TO EXPERT WITHIN THE CARE UNIT. THE PATIENT INITIALS ARE (B)(6), MALE, BORN ON (B)(6) 1997. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: Erythema; Pain; Swelling/ Edema; Vasculitis

  MAUDE report 24500294 ↗
• MalfunctionFeb 16, 2026Complete Blockage

  IT WAS STATED THAT A PHLEBITIS OCCURRED IN SEVERAL PATIENTS FOLLOWING THE INSERTION OF CATHETERS, IN THE HOSPITAL. THE PACKAGING IS INTACT AND NO VISIBLE DEFECT WAS OBSERVED. HOWEVER, DURING CATHETER INSERTION, THERE WAS NO BLOOD RETURN EVEN THOUGH THE DEVICE WAS CORRECTLY POSITIONED IN THE VEIN. THERE WAS PATIENT INVOLVEMENT AND CLINICAL SIGNS WERE REPORTED, INCLUDING EDEMA, PAIN, SIGNIFICANT REDNESS, AND IN ONE CASE A THROMBOSIS.

  Patient problems: Pain; Thrombosis/Thrombus; Vasculitis

  MAUDE report 24349332 ↗
• MalfunctionDec 1, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN THE CUSTOMER ATTEMPTED TO REMOVE THE CAP FROM THE CATHETER, THE CAP WAS BENT AND MISSHAPED, CAUSING A CUT TO HER RIGHT HAND THAT REQUIRED STITCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682002 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464633 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464626 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464613 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464606 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464603 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464596 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464594 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464580 ↗
• MalfunctionNov 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER, IT WAS NOTED THAT A TOTAL OF NINE DEFECTIVE DEVICES WERE IDENTIFIED, INVOLVING FOUR PATIENTS, WITH THREE DEVICES REPORTEDLY USED ON A SINGLE PATIENT. THE EVENT OCCURRED DURING PATIENT USE. PATIENT ADVERSE EFFECTS, IF ANY, ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464576 ↗
• MalfunctionJun 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DURING REMOVAL OF THE MANDREL, THE DEVICE GOT STUCK AND DETACHED THE SILICON PART WHERE IT BROKE AND RUPTURED THE VEIN. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330982 ↗
• MalfunctionJun 24, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT WHILE INITIATING AN INTRAVENOUS (IV) LINE, THE NEEDLE WAS WITHDRAWN FROM THE CANNULA AND PLACED ON THE BED. AS IT WAS BEING PICKED UP FOR DISPOSAL, IT PRICKED THE LEFT PINKY FINGER, CAUSING BLEEDING. THE CANNULA APPEARED TO BE DEFECTIVE, AS ITS SAFETY LOCKING MECHANISM DID NOT WORK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Needle Stick/Puncture

  MAUDE report 22319786 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK AT THE SPONGE SITE CAUSING BLOOD TO GET EVERYWHERE. THE EVENT OCCURRED DURING USE ON PATIENT, AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205531 ↗
• MalfunctionMay 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER WAS AT RISK OF LEAKAGE AND PERFORATION BY THE TECHNICIAN THAT WAS PERFORMING THE PUNCTURE. THE MATERIAL DETACHED FROM THE PLASTIC PART WHEN INSERTED INTO VEIN. EVENT OCCURRED DURING PUNCTURE. THERE WAS PATIENT INVOLVEMENT, THE ADVERSE EVENT WAS NON-SEVERE AND THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096478 ↗
• MalfunctionApr 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING CATHETER PLACEMENT, THE MANDREL GUARD FILLED WITH BLOOD AND STAINED THE PATIENT, SOIL AND THE NURSE¿S UNIFORM. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927457 ↗
• MalfunctionMar 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE CLINICIAN ATTEMPTED TO PULL BACK THE NEEDLE FROM IV CANNULA, BUT WAS UNABLE TO ACTIVATE NEEDLE REMOVAL SAFETY MECHANISM. THE CLINICIAN REMOVED BOTH NEEDLE AND IV CANNULA AND NOTED SMALL HEMATOMA AFTER REMOVAL.

  Patient problems: Hematoma

  MAUDE report 21734880 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THEY HAD A 22-GAUGE IV LEAK AT THE SPONGE SITE CAUSING BLOOD TO GET EVERYWHERE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21544056 ↗