INTROCAN SAFETY® 4251717-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 14 Ga. x 2 in., PUR, Straight · Class 2
All models of INTROCAN SAFETY (46)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046963189105), received between Sep 6, 2017 and Sep 6, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 6, 2017Break; Break
AS REPORTED BY USER FACILITY: THE CATHETER WOULD NOT ADVANCE AND AS TENSION WAS LET OFF THE CATHETER SLID BACK ONTO THE NEEDLE. THE NEEDLE WAS REMOVED FROM THE CATHETER TO ENGAGE THE SAFETY APPARATUS AND THEN THE CATHETER WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT A PORTION OF THE TIP OF THE CATHETER WAS SHEARED OFF.
Patient problems: No Information
MAUDE report 6844735 ↗
Other INTRODUCER, CATHETER devices
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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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