INTROCAN SAFETY® 4251687-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04046963165987), received between Apr 18, 2018 and Dec 23, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Protective Measures Problem” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: INTROCAN IV CATHETER 4251687-02 FAILED DURING THERAPY. CATHETER BROKE OFF FROM HUB UPON REMOVAL; CATHETER PIECE REMAINS INSIDE PATIENT AND WILL BE EVALUATED BY A VASULAR SURGEON TODAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23878188 ↗
• MalfunctionDec 30, 2024Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: INJURIES OR ADVERSE EVENT: NO. REPORTED ISSUE: CUSTOMER, (B)(6) EMAILED, "IT HAS COME TO OUR ATTENTION FROM ONE OF OUR DEPARTMENTS OF THE SAFETY CONCERNS OF THE NEEDLE AS IT IS NOT ENCLOSED BY A SAFETY BARRIER, WHICH MAY INCREASE THE RISK OF POTENTIAL STICKS. I WANT KNOW IF IT WOULD BE POSSIBLE TO RETURN 4 CASES OF THIS ITEM TO MEDLINE. I'VE ATTACHED A PHOTO OF THE NEEDLE. THE CONCERNS ARE WITH THE NEEDLE TIP AFTER IT HAS BEEN USED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21040970 ↗
• MalfunctionJul 15, 2022Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: "WE HAD A SAFETY EVENT WITH AN INTROCAN IV CATHETER WHERE THE SAFETY GUARD DID NOT ACTIVATE PROPERLY AND THE NEEDLE WAS STILL EXPOSED." NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15025870 ↗
• MalfunctionJun 12, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CLINICIAN WENT TO START IV ON PATIENT AND NOTICED WHAT APPEARS TO BE BLOOD ALREADY IN THE CATHETER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672363 ↗
• MalfunctionApr 14, 2022Break; Break

  AS REPORTED BY THE USER FACILITY: IV CATHETER WAS PLACED IN PATIENT'S HAND (B)(6) 2022. IT REMAINED IN PLACE WORKING FINE FOR FULL LENGTH OF STAY UNTIL (B)(6) 2022. ON REMOVAL A PART OF THE CATHETER WAS RETAINED IN THE PATIENT'S HAND. REQUIRED SURGERY FOR VEIN RESECTION TO REMOVE THE CATHETER PART.

  Patient problems: Foreign Body In Patient

  MAUDE report 14110786 ↗
• MalfunctionJan 22, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem

  AS REPORTED BY THE USER FACILITY: A NURSE WAS STUCK BY ONE OF THE IV NEEDLES AFTER THE SAFETY MECHANISM HAD BEEN ACTIVATED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11215083 ↗
• MalfunctionMar 11, 2020Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY THE USER FACILITY: A CLINICIAN SUCCESSFULLY PLACED AN INTROCAN IV AND WHEN SHE WAS CLEANING UP, SHE GOT A NEEDLE STICK. WHEN SHE TOOK A CLOSER LOOK AT THE NEEDLE SHE NOTICED THAT THE SAFETY SHIELD DID NOT ACTIVATE.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9819872 ↗
• MalfunctionNov 26, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY THE USER FACILITY: "DURING AN INTROCAN DEMO TO A COLLEAGUE, WHILE SHOWCASING THE SAFETY FEATURE OF INTROCAN, A NURSE DID NOT REALIZE THE SHIELD WAS DISPLACED FROM THE TIP OF THE NEEDLE, AND PRICKED HERSELF."

  Patient problems: Needle Stick/Puncture

  MAUDE report 9375882 ↗
• MalfunctionOct 1, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: WHEN PUTTING THE DEVICE IN A SHARPS CONTAINER THE NURSE RECEIVED A NEEDLE STICK.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9142160 ↗
• MalfunctionAug 26, 2019Protective Measures Problem; Protective Measures Problem

  AS REPORTED BY USER FACILITY: EVENT 2. WHILE CARRYING A TRASH BAG THE PROVIDER WAS IMPALED WITH A USED UNIT. UPON EXAMINATION, THE UNIT'S SAFETY DEVICE WAS NOT ENGAGED, RATHER HALF-WAY BACK ON THE STYLET.

  Patient problems: Needle Stick/Puncture

  MAUDE report 8932777 ↗
• MalfunctionApr 18, 2018Break; Break

  AS REPORTED BY USER FACILITY: INSERTED IV CATHETER, ADVANCED CATHETER, AND NEEDLE WAS REMOVED. SWELLING WAS NOTED DISTAL TO INSERTION SITE. PATIENT WAS BLEEDING. IV CATHETER REMOVED AND PRESSURE HELD. UPON INSPECTION OF IV CATHETER, IV CATHETER WAS BROKEN IN HALF. A NEW IV WAS INSERTED. NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7440881 ↗