INTROCAN SAFETY® 4253523-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 24 Ga. x 0.75 in., PUR, Winged · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963318239), received between Jul 5, 2017 and May 15, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (1 report).
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
Device problems
- Fail-Safe Problem1
- Fluid/Blood Leak1
- Protective Measures Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Perforation of Vessels1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: "AFTER CONFIRMING 24G PIV WAS SUCCESSFULLY PLACED IN PATIENT'S LEFT AC VESSEL, I CONTINUED TO ADVANCE CATHETER OFF OF THE NEEDLE INTO THE VESSEL AND RELEASED THE TOURNIQUET. THE VESSEL WAS OCCLUDED AND CATHETER HUB WAS STABILIZED. WHEN REMOVING THE NEEDLE FROM THE HUB, I MET RESISTANCE AND WAS UNABLE TO SUCCESSFULLY DISCONNECT THE NEEDLE FROM THE HUB. BECAUSE OF THIS, THE CATHETER WAS REMOVED FROM THE PATIENT'S VESSEL WITH THE NEEDLE STILL IN HUB. THIS CAUSED TRAUMA TO MY PATIENT'S DELICATE VESSELS AND PLACED ME AT AN INCREASED RISK FOR A NEEDLESTICK OR BLOOD-BORNE PATHOGEN EXPOSURE."
Patient problems: Perforation of Vessels
MAUDE report 16930834 ↗MalfunctionApr 11, 2019Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY USER FACILITY: DURING INSERTION AND THREADING OF THE CATHETER IT WAS OBSERVED THAT BLOOD WAS LEAKING AT THE CONNECTION WHERE THE CATHETER MEETS THE HUB.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8503506 ↗MalfunctionJul 5, 2017Protective Measures Problem; Protective Measures Problem
AS REPORTED BY USER FACILITY: SAFETY DEVICE DID NOT ENGAGE. NO INJURY OR NEEDLE STICKS OCCURRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6686537 ↗
Other INTRODUCER, CATHETER devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 reports
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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