INTROCAN SAFETY 3Recalls & reported problems across all models

We found 5 models of INTROCAN SAFETY 3 by B. Braun Medical Inc. in the FDA's device registry (GUDID). Together they are named in 86 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2017 and Sep 29, 2026 — classified as 2 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (29 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

INTROCAN SAFETY 3 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Feb 17, 2025Open, Classified

   Increased risk for valve housing detachment causing leakage.

   Z-1397-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported INTROCAN SAFETY 3 problems

INTROCAN SAFETY 3 models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• INTROCAN SAFETY® 3 4251128-02

  Catheter,intravascular,therapeutic,short-term less than 30 days
  1 recall19 reports
• INTROCAN SAFETY® 3 4251129-02

  Catheter,intravascular,therapeutic,short-term less than 30 days
  43 reports
• INTROCAN SAFETY® 3 4251131-02

  Catheter,intravascular,therapeutic,short-term less than 30 days
  12 reports
• INTROCAN SAFETY® 3 4251130-02

  Catheter,intravascular,therapeutic,short-term less than 30 days
  7 reports
• INTROCAN SAFETY® 3 4251127-02

  Catheter,intravascular,therapeutic,short-term less than 30 days
  5 reports

Recent INTROCAN SAFETY 3 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928021 ↗
• MalfunctionFeb 11, 2026Fail-Safe Problem

  AS REPORTED BY USER FACILITY: IV CATHETER WAS USED FOR IV INSERTION. THERE WAS NO ISSUE WITH THE INSERTION. WHEN THE NURSE RETRACTED THE NEEDLE FROM THE CATHETER, THE PROTECTIVE COVER DID NOT COVER THE NEEDLE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24312667 ↗
• MalfunctionDec 23, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: THE VALVES ARE FAULTY, ALLOWING BLOOD TO GO BACKWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877714 ↗
• MalfunctionOct 22, 2025Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: OR COORDINATOR STATES THAT A COUPLE WEEKS AGO A 20G IS3 CATHETER WAS PLACED AND WHEN RETRACTING THE NEEDLE THE SAFETY MECHANISM ENGAGED BUT DID NOT FULLY COVER THE TIP OF THE NEEDLE LEAVING AN EXPOSED SHARP. THE NEEDLE WAS NOT RETAINED. THE LOT NUMBER WAS NOT CONFIRMED. THE LOT RECORDED HERE IS WHAT IS CURRENTLY ON THE SHELF AT THE FACILITY. PATIENT INJURY NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357896 ↗
• MalfunctionSep 18, 2025Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION NEEDLE GOT CAUGHT IN SAFETY AND COULD NOT REMOVE FROM CATHETER HUB DETAILED INQUIRY DESCRIPTION WHILE REMOVING STYLET, NEEDLE WAS CAUGHT ON SAFETY AND COULD NOT BE REMOVED OR ACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23088954 ↗
• MalfunctionSep 12, 2025Difficult to Advance; Fail-Safe Problem; Difficult to Advance; Fail-Safe Problem

  ACCORDING TO THE EVENT DESCRIPTION THE CATHETER PASSIVE SAFETY MECHANISM DID NOT ENGAGE WHEN REMOVING STYLETTE FROM PATIENT , ANOTHER WAS DIFFICULT TO THREAD. THE SAFETY THAT IS SUPPOSED TO ENGAGE WHEN REMOVED FROM THE PLASTIC CATHETER HOUSING WHEN REMOVING THE NEEDLE FROM THE PATIENT FAILED TO COVER THE SHARP END OF THE NEEDLE ON MULTIPLE NEEDLES FROM THIS SAME LOT NUMBER. A THIRD WAS DIFFICULT TO ADVANCE THE PLASTIC CATHETER OFF THE NEEDLE INTO THE VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036451 ↗
• MalfunctionAug 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION DEFECTIVE PRODUCT INTROCAN 3. DETAILED INQUIRY DESCRIPTION THERE WERE SEVERAL NEW INTROCAN 3 PRODUCTS WITH DEBRIS ON THE CATHETER. IT APPEARED TO BE EXTRA MATERIAL FROM THE MOLDING PROCESS. THEY THREW THEM ALL AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715651 ↗
• MalfunctionJul 10, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: REASON: VENDOR DEFECTIVE - THEY ARE NOT SELF OCCLUDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22467763 ↗
• MalfunctionJul 1, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE COMPLAINANT, THE DEVICE WAS NOT SELF-OCCLUDING. ADDITIONAL INFORMATION WAS RECEIVED WHICH REVEALED THAT THE "THE BLOOD CONTROL PART OF THE IV WAS NOT WORKING PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22375853 ↗
• MalfunctionJun 2, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: REPORTED ISSUE: UPON OPENING PACKAGE, CATHETER WAS BROKEN/BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126518 ↗
• MalfunctionJun 2, 2025Break; Break

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: WHILE PLACING THE CATHETER, THE IV NEEDLE WAS PARTIALLY PULLED BACK AND THEN REINSERTED. NEEDLE APPEARS SEPARATED/ SPLIT FROM THE CATHETER ITSELF. DETAILED INQUIRY DESCRIPTION: PRODUCT CODE: 4251128-02 EXPIRATION DATE: 1/1/30 LOT NUMBER: 25A04G8952. PATIENT WAS INVOLVED BUT CUSTOMER HAS NOT GOTTEN BACK WITH PATIENT INFORMATION TO FILE. DESCRIPTION OF THE PATIENT EVENT: IV PLACED, MINIMAL FLASH SEEN IN CHAMBER, ATTEMPTED TO CONTINUE PLACEMENT, CLIENT COMPLAINED OF PAIN, IV REMOVED, CATHETER SEEN SPLIT (APPEARED TO BE INTACT OTHERWISE/NO PIECES MISSING).

  Patient problems: Needle Stick/Puncture

  MAUDE report 22125746 ↗
• MalfunctionMay 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE EVENT DESCRIPTION, "PATIENT INTER TO UCI WITH SEPTIC DISRUPTIVE SHOCK, TRI-VALVULAR INSUFFICIENCY, URINARY TRACT INFECTION AND RENAL FAILURE HAVE PHLEBITIS AT THE SITE OF THE PUNCTION."

  Patient problems: Vasculitis

  MAUDE report 22097266 ↗
• MalfunctionApr 24, 2025Fail-Safe Problem; Fail-Safe Problem

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION INTROCAN SAFETY 3 SAFETY DID NOT COVER NEEDLE TIP DETAILED INQUIRY DESCRIPTION CUSTOMER HAS REPORTED THAT THE SAFETY SHEILD ON AN INTROCAN SAFETY 3 22G DID NOT COVER THE NEEDLE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21898828 ↗
• MalfunctionApr 2, 2025Mechanical Problem; Mechanical Problem

  AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION FAILED BLOOD CONTROL WHEN INTROCAN SAFETY 3 CLOSED IV CATHETER (MULTI ACCESS BLOOD CONTROL) 20G CATHETER. MULTIPLE STAFF NOTED RECENT INTERMITTENT ISSUES WITH BLOOD CONTROL DEVICE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751002 ↗
• MalfunctionMar 31, 2025Leak/Splash; Leak/Splash

  AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION BLOOD CONTROL NOT WORKING DETAILED INQUIRY DESCRIPTION BLEEDING OUT THE SAFETY END DESCRIPTION OF THE PATIENT EVENT BLOOD BLEEDING OUT END OF IV AFTER STARTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21731011 ↗

Other B. Braun Medical Inc. products

• Infusomat54 models · 2,783 reports · 30 recalls
• IV Administration Set153 models · 281 reports · 68 recalls
• Hemodialysis Bloodlines9 models · 2,179 reports · 14 recalls
• Outlook25 models · 195 reports · 24 recalls
• Perifix57 models · 224 reports · 20 recalls
• Extension Set41 models · 101 reports · 16 recalls
• Design Options116 models · 132 reports · 14 recalls
• Blood Administration Set24 models · 177 reports · 13 recalls