INTROCAN SAFETY® 4253566-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 20 Ga. x 1.25 in., PUR, Winged · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963318253), received between May 10, 2021 and Nov 26, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (3 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.
Reports received per month
Most reported problems
Device problems
- Fail-Safe Problem3
- Device Handling Problem1
Patient problems
- Needle Stick/Puncture2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 26, 2024Fail-Safe Problem; Fail-Safe Problem
ACCORDING TO THE EVENT DESCRIPTION: A NURSE WAS PUNCTURED HERSELF WHILE DISPOSING OF THE NEEDLE, AFTER THE SAFETY DEVICE HAD ALREADY TRIGGERED BUT NOT PROPERLY.
Patient problems: Needle Stick/Puncture
MAUDE report 20788189 ↗MalfunctionApr 11, 2023Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: CUSTOMER REPORTS THAT AFTER INSERTION OF A 20G NEEDLE THE STYLET WAS RETRACTED FROM THE HUB AND THE SAFETY SHIELD FAILED TO PROPERLY CONTAIN THE NEEDLE TIP. IT INSTEAD WAS REMOVED WITH THE STYLET AND MAINTAINED IN ITS MOST REAR POSITION. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16712232 ↗MalfunctionMay 10, 2021Fail-Safe Problem; Device Handling Problem; Fail-Safe Problem; Device Handling Problem
AS REPORTED BY USER FACILITY: SAFETY ON CATHETER DID NOT ENGAGE WHICH RESULTED IN NEEDLESTICK.
Patient problems: Needle Stick/Puncture
MAUDE report 11798585 ↗
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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