Jelco 3055Recalls & reported problems
Icu Medical, Inc. · GTIN for PRO 18 X 1 1/4 Each · Class 2
All models of Jelco (101)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10351688071095), received between Oct 3, 2017 and May 28, 2025 — classified as 6 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (8 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.
Reports received per month
Most reported problems
Device problems
- Leak/Splash8
- Detachment of Device or Device Component4
- Break3
- Disconnection2
- Device-Device Incompatibility1
- Difficult to Remove1
- Material Deformation1
- Material Fragmentation1
Patient problems
- No Consequences Or Impact To Patient8
- Foreign Body In Patient5
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient2
- Distress1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
InjuryMay 28, 2025Break; Disconnection; Break; Disconnection
IT WAS REPORTED THAT CATHETER TIP WAS NOT PRESENT UPON REMOVAL FROM PATIENT¿S ARM AT TIME OF DISCHARGE. STAFF THOUGHT THAT THE CATHETER BROKE OFF FROM HUB IN TWO DIFFERENT PATIENTS. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT OR CLINICIAN INJURY. AFTER THE IV CATHETER WAS VISUALIZED IN THE PATIENT¿S ARM, THE VASCULAR TEAM WAS CONSULTED TO REMOVE IT FROM THE PATIENT¿S VEIN. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, AND A CEPHALIC VEIN LIGATION WAS PERFORMED. THE PATIENT REMAINED IN THE HOSPITAL AFTER SURGERY AN ADDITIONAL DAY AND WAS DISCHARGED ON (B)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22096473 ↗MalfunctionMay 16, 2024Disconnection; Device-Device Incompatibility; Disconnection; Device-Device Incompatibility
IT WAS REPORTED THAT THE CUSTOMER NEEDS TO TEST THE COMPATIBILITY OR MATING OF THE CATHETERS TO THEIR ITEM NUMBER. IT ALSO STATED THAT THEIR CUSTOMER IS SAYING THAT THE EXTENSION SET AND/OR MALE LUER POPS OFF THE CATHETER FEMALE LUER DURING CT INJECTION. THIS IS INTERMITTENT, BUT THEY HAVE SEEN AN INCREASE. THEY WANT TO VERIFY THAT ALL ITEMS ARE IN SPEC AND VALIDATE UNDER HIGH PRESSURE INJECTION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED. DATE OF EVENT WAS IN MARCH/APRIL STILL ON GOING. THE EVENT OCCURS AT CT. AFFECTED QUANTITY REPORTED AS 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19330938 ↗MalfunctionMay 8, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE DEVICE SHEAR WHEN WITHDRAWING THE INTRAVENOUS (IV).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16885306 ↗InjuryJun 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED PER MEDWATCH (B)(4): UPON ASSESSMENT OF PIV, IT WAS NOTED THAT CATHETER WAS MISSING. SITE ASSESSED AND FELT AS IF CATHETER WAS STILL IN PATIENTS ARM. ULTRASOUND CONFIRMED IV CATHETER RETENTION. A CLINICAL DECISION MADE NOTING THE BENEFIT OF REMOVING THE FOREIGN BODY DID NOT OUTWEIGH THE RISK.
Patient problems: Distress; Foreign Body In Patient
MAUDE report 14875672 ↗MalfunctionMay 26, 2022Difficult to Remove; Detachment of Device or Device Component
UPON ASSESSMENT OF PIV, IT WAS NOTED THAT CATHETER WAS MISSING. SITE ASSESSED AND FELT AS IF CATHETER WAS STILL IN PATIENTS ARM. ULTRASOUND CONFIRMED IV CATHETER RETENTION. CLINICAL DECISION MADE NOTING THE BENEFIT OF REMOVING THE FOREIGN BODY DID NOT OUTWEIGH THE RISK.
Patient problems: Foreign Body In Patient
MAUDE report 14512288 ↗InjuryMar 25, 2022Break; Break
IT WAS REPORTED THAT DURING THE REMOVAL OF THE CATHETER, PRIOR TO DISCHARGE, THE NURSE NOTICED THAT AFTER SHE PULLED THE HUB BACK ONLY ABOUT 2MM (1/16") OF THE CATHETER REMAINED ON THE HUB. THE REMAINING 1 3/16" OF THE CATHETER REMAINED WITHIN THE PATIENT. AFTER AN X-RAY WAS OBTAINED THE RADIOLOGIST REPORTED THAT; "THERE IS AN IV CATHETER INVOLVING THE SOFT TISSUES OF THE MEDIAL ASPECT OF THE RIGHT ELBOW." THE CATHETER WAS REMOVED BY THE GENERAL SURGEON, RESOLVING THE REPORTED EVENT.
Patient problems: Foreign Body In Patient
MAUDE report 13905143 ↗InjuryJul 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION RECEIVED A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV CATHETERS BROKE OFF DURING IV ATTEMPT. IV HAD TO BE SURGICALLY REMOVED FROM PATIENTS ARM BY EMERGENCY ROOM "DEPORTMENT" MD.
Patient problems: Foreign Body In Patient
MAUDE report 12147783 ↗InjuryJul 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION RECEIVED A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC)/JELCO SAFETY PROTECTIV CATHETERS BROKE OFF DURING IV ATTEMPT. IV HAD TO BE SURGICALLY REMOVED FROM PATIENTS ARM BY ER DEPORTMENT MD.
Patient problems: Foreign Body In Patient
MAUDE report 12147717 ↗MalfunctionAug 1, 2018Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE NURSING STAFF WAS HAVING GREAT DIFFICULTY GETTING THE BLOOD TO DRAW WITH THE JELCO SAFETY PROTECTIV CATHETER. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7740933 ↗InjuryDec 27, 2017Break; Material Fragmentation; Material Deformation; Break; Material Fragmentation; Material Deformation
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL JELCO® PROTECTIV® SAFETY I.V. CATHETER BROKE OFF AND REMAINED IN THE PATIENT. SIX HOURS FOLLOWING, THE SEVERED CATHETER WAS RETRIEVED. THE PATIENT RECOVERED WITH NO ADVERSE EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7147776 ↗MalfunctionOct 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SMITHS MEDICAL JELCO®PROTECTIV® SAFETY I.V. CATHETER HAD "GUSHED" BLOOD OUT OF THE FLASH CHAMBER AND ONTO THE SKIN. THE CATHETER WAS NOTED TO BE THREADED TO SKIN LINE WITH FULL NEEDLE RETRACTION AND LOCK OUT WHEN THE BLOOD "GUSHED" PASS THE FLASH CHAMBER AND WENT INTO THE HOUSING UNIT. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6912308 ↗MalfunctionOct 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SMITHS MEDICAL JELCO®PROTECTIV® SAFETY I.V. CATHETER HAD "GUSHED" BLOOD OUT OF THE FLASH CHAMBER AND ONTO THE SKIN. THE CATHETER WAS NOTED TO BE THREADED TO SKIN LINE WITH FULL NEEDLE RETRACTION AND LOCK OUT WHEN THE BLOOD "GUSHED" PASS THE FLASH CHAMBER AND WENT INTO THE HOUSING UNIT. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6912293 ↗MalfunctionOct 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SMITHS MEDICAL JELCO®PROTECTIV® SAFETY I.V. CATHETER HAD "GUSHED" BLOOD OUT OF THE FLASH CHAMBER AND ONTO THE SKIN. THE CATHETER WAS NOTED TO BE THREADED TO SKIN LINE WITH FULL NEEDLE RETRACTION AND LOCK OUT WHEN THE BLOOD "GUSHED" PASS THE FLASH CHAMBER AND WENT INTO THE HOUSING UNIT. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6912265 ↗MalfunctionOct 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SMITHS MEDICAL JELCO®PROTECTIV® SAFETY I.V. CATHETER HAD "GUSHED" BLOOD OUT OF THE FLASH CHAMBER AND ONTO THE SKIN. THE CATHETER WAS NOTED TO BE THREADED TO SKIN LINE WITH FULL NEEDLE RETRACTION AND LOCK OUT WHEN THE BLOOD "GUSHED" PASS THE FLASH CHAMBER AND WENT INTO THE HOUSING UNIT. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6912262 ↗MalfunctionOct 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SMITHS MEDICAL JELCO®PROTECTIV® SAFETY I.V. CATHETER HAD "GUSHED" BLOOD OUT OF THE FLASH CHAMBER AND ONTO THE SKIN. THE CATHETER WAS NOTED TO BE THREADED TO SKIN LINE WITH FULL NEEDLE RETRACTION AND LOCK OUT WHEN THE BLOOD "GUSHED" PASS THE FLASH CHAMBER AND WENT INTO THE HOUSING UNIT. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6912255 ↗MalfunctionOct 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SMITHS MEDICAL JELCO®PROTECTIV® SAFETY I.V. CATHETER HAD "GUSHED" BLOOD OUT OF THE FLASH CHAMBER AND ONTO THE SKIN. THE CATHETER WAS NOTED TO BE THREADED TO SKIN LINE WITH FULL NEEDLE RETRACTION AND LOCK OUT WHEN THE BLOOD "GUSHED" PASS THE FLASH CHAMBER AND WENT INTO THE HOUSING UNIT. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6912239 ↗MalfunctionOct 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SMITHS MEDICAL JELCO®PROTECTIV® SAFETY I.V. CATHETER HAD "GUSHED" BLOOD OUT OF THE FLASH CHAMBER AND ONTO THE SKIN. THE CATHETER WAS NOTED TO BE THREADED TO SKIN LINE WITH FULL NEEDLE RETRACTION AND LOCK OUT WHEN THE BLOOD "GUSHED" PASS THE FLASH CHAMBER AND WENT INTO THE HOUSING UNIT. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6912217 ↗MalfunctionOct 3, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A SMITHS MEDICAL JELCO®PROTECTIV® SAFETY I.V. CATHETER HAD "GUSHED" BLOOD OUT OF THE FLASH CHAMBER AND ONTO THE SKIN. THE CATHETER WAS NOTED TO BE THREADED TO SKIN LINE WITH FULL NEEDLE RETRACTION AND LOCK OUT WHEN THE BLOOD "GUSHED" PASS THE FLASH CHAMBER AND WENT INTO THE HOUSING UNIT. THE CATHETER WAS REMOVED AND A NEW ONE WAS PLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6912215 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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