Fast-Cath™ 406961Recalls & reported problems
St. Jude Medical, Inc. · HEMOSTASIS INTRODUCER · Class 2
All models of Fast-Cath (71)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734204026), received between May 15, 2019 and May 28, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak2
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Gas/Air Leak; Gas/Air Leak
DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AFTER INSERTING THE SHEATH, AIR WAS ASPIRATED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22097067 ↗MalfunctionJan 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ELECTROPHYSIOLOGY PROCEDURE WHEN PUNCTURING THROUGH THE FEMORAL VEIN, REGURGITATION FROM THE HEMOSTATIC VALVE WAS OBSERVED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18579968 ↗MalfunctionFeb 15, 2021Gas/Air Leak; Gas/Air Leak
DURING A PSVT ABLATION PROCEDURE, AN AIR LEAK OCCURRED. AFTER PLACING THE SHEATH, PRIOR TO CATHETER INSERTIONS, AIR WAS ASPIRATED INTO THE SYRINGE THAT CONNECTED TO THE EXTENSION PORT. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. THE DEVICE WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11329976 ↗MalfunctionMay 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
FOLLOWING AN ATRIAL FLUTTER PROCEDURE, THE TRIPLE VALVE HAD DETACHED FROM THE HUB OF THE SHEATH WHILE BEING REMOVED FROM THE PATIENT. THE PROCEDURE HAD BEEN SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8611694 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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