INTROCAN SAFETY® 4252586-02Recalls & reported problems
B. Braun Medical Inc. · Introcan Safety® IV Catheter 16 Ga. x 1.25 in., FEP, Straight · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046963318215), received between Feb 25, 2022 and Jun 19, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Fail-Safe Problem1
Patient problems
- Foreign Body In Patient2
- 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.
InjuryJun 19, 2026Break
AS REPORTED BY THE USER FACILITY: INTROCAN CATHETER CANNULA SEPARATED. CUSTOMER EXPERIENCED AN ISSUE WITH A RETAINED PORTION OF THE CATHETER IN A PATIENT. AS PART OF AN INTERNAL NONCONFORMANCE, THIS IMPORTER MDR IS BEING SUBMITTED RETROACTIVELY. PLEASE NOTE THAT THE ASSOCIATED MANUFACTURER MDR FOR THIS EVENT, 9610825-2022-00062, HAD ALREADY BEEN PREVIOUSLY SUBMITTED TIMELY ON 08MAR2022. AS B. BRAUN MEDICAL, INC. SUBMITTED THE MANUFACTURER MDR ON BEHALF OF THE MANUFACTURER, THE IMPORTER MDR WAS INADVERTENTLY MISSED.
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 25562090 ↗MalfunctionMar 8, 2022Break; Break
AS REPORTED BY THE USER FACILITY: INTROCAN CATHETER CANNULA SEPARATED. CUSTOMER EXPERIENCED AN ISSUE WITH A RETAINED PORTION OF THE CATHETER IN A PATIENT.
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 13693958 ↗MalfunctionFeb 25, 2022Fail-Safe Problem; Fail-Safe Problem
AS REPORTED BY THE USER FACILITY: SAFETY FEATURE ON NEEDLES DOES NOT WORK PROPERLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13599985 ↗
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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