Intradyn™ 610652Recalls & reported problems
B. Braun Medical Inc. · 10HI12038 12F X 11CM HEMO W/WI · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04046964331572), received between Nov 30, 2016 and Dec 20, 2017 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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.
Most reported problems
Device problems
- Fluid/Blood Leak4
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 2: EXCESSIVE LEAKING OCCURRED WITH THE VALVE. BLOOD LEAKED BACK DURING THE PROCEDURE. NO ADVERSE EVENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7135375 ↗MalfunctionDec 20, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 1: EXCESSIVE LEAKING OCCURRED WITH THE VALVE. BLOOD LEAKED BACK DURING THE PROCEDURE. NO ADVERSE EVENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7135371 ↗MalfunctionDec 20, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 4: EXCESSIVE LEAKING OCCURRED WITH THE VALVE. BLOOD LEAKED BACK DURING THE PROCEDURE. NO ADVERSE EVENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7135370 ↗MalfunctionDec 20, 2017Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: EVENT 3: EXCESSIVE LEAKING OCCURRED WITH THE VALVE. BLOOD LEAKED BACK DURING THE PROCEDURE. NO ADVERSE EVENT REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7135364 ↗MalfunctionNov 30, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected
AS REPORTED BY USER FACILITY: VALVE LEAKING BLOOD.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6134507 ↗
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- 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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