Fast-Cath™ 406180Recalls & reported problems
St. Jude Medical, Inc. · Class 2
Quick summary
This Fast-Cath introducer sheath from St. Jude Medical is used to guide catheters into the heart. All 23 reports describe malfunctions, most often blood leaking from the device's hemostatic valve during atrial fibrillation procedures; the sheath was typically replaced and procedures finished without harm to the patient, with no deaths and no injuries reported. No recalls name this device. Reports have fallen sharply, with 1 in the last 12 months compared to 14 in the prior period.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05414734014410), received between Mar 5, 2019 and Dec 16, 2025 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (16 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak16
- Gas/Air Leak3
- Material Separation3
- Fracture1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE INTRODUCER WAS INSERTED INTO THE PATIENT, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. 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 23816169 ↗MalfunctionJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE CRYOABLATION PROCEDURE, THE LEAKAGE OF BLOOD AND SALINE WAS NOTED FROM THE VALVE. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE INTRODUCER, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22579654 ↗MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER THE TRANSEPTAL PUNCTURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. ONLY VIEWFLEX CATHETER WAS INSERTED INTO THE SHEATH. THE TRANSSEPTAL NEEDLE WAS FROM JAPANLIFE LINE. THE MODEL AND LOT NUMBER ARE UNKNOWN. THE DEVICES INSERTED DIRECTLY INTO THE HEMOSTATIC VALVE UNTIL THE REPORTED EVENT OCCURRED WERE THE DILATOR AND VIEWFLEX. NO ABNORMALITIES WERE NOTED WITH THE FIRST DEVICE INSERTED INTO THE SHEATH¿S HEMOSTASIS VALVE. THERE WAS NO MOVEMENT OF AIR INTO THE PATIENT¿S BODY. NO ADDITIONAL PUNCTURE AT THE ACCESS SITE WAS NECESSARY DURING SHEATH REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22341648 ↗MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE INTRODUCER WAS INSERTED INTO THE PATIENT, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER. ONLY THE DILATOR WAS INSERTED. THE ISSUE OCCURRED IMMEDIATELY AFTER THE INTRODUCER WAS INSERTED INTO THE PATIENT'S BODY. NO AIR LEAK OR AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. NO ADDITIONAL PUNCTURE SITE WAS REQUIRED TO REPLACE THE INTRODUCER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22340478 ↗MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE PATIENT, AND WHEN INSERTING THE VIEWFLEX CATHETER INTO THE SHEATH, BLOOD LEAKED. 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 22310439 ↗MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, AFTER THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND THE VIEWFLEX CATHETER WAS INSERTED, BLOOD LEAKED FROM THE HEMOSTASIS VALVE WHEN INSERTING THE HALO CATHETER. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292788 ↗MalfunctionMay 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH AFTER INSERTION. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22083034 ↗MalfunctionMay 21, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE SHEATH EIGHT AFTER INSERTION INTO THE PATIENT. 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 22063835 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, BLOOD LEAKED FROM THE SHEATH HEMOSTASIS VALVE. 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 22038755 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE PFA PROCEDURE, BLOOD LEAKED FROM THE VALVE. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE INTRODUCER, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035900 ↗MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, WHILE OPERATING THE MAPPING CATHETER IN THE LEFT ATRIUM, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. 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 22029901 ↗MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL TACHYCARDIA PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH AT THE END OF THE BROCKENBROUGH. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21991120 ↗MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. 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 21991092 ↗MalfunctionMay 1, 2025Gas/Air Leak; Gas/Air Leak
DURING THE PFA PROCEDURE USING ENSITE X, AN AIR LEAK WAS NOTED FROM THE HEMOSTASIS VALVE, AND AIR ENTERED THE SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE INTRODUCER, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21944544 ↗MalfunctionNov 26, 2024Material Separation; Material Separation
IT IS REPORTED THAT DURING A WATCHMAN PROCEDURE WITH ULTRASOUND, THE SIDEPORT BROKE OFF FROM THE INTRODUCER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20778085 ↗MalfunctionJul 12, 2024Material Separation; Material Separation
DURING THE PROCEDURE, THE SIDEPORT OF THE INTRODUCER SHEATH CAME APART DURING FLUSHING. A NEW INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19730720 ↗MalfunctionNov 9, 2021Fluid/Blood Leak; Fluid/Blood Leak
DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. FOLLOWING INSERTION INTO THE PATIENT, AND AFTER INSERTING A VEIWFLEX CATHETER INTO THE SHEATH, BLOOD WAS NOTED FROM THE HEMOSTASIS VALVE OF THE SHEATH. THE SHEATH SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL FEMORAL VEIN PUNCTURE WAS REQUIRED FOR REPLACING THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12782627 ↗MalfunctionMay 20, 2021Gas/Air Leak; Gas/Air Leak
DURING THE PROCEDURE, THE SHEATH WAS INSERTED AND FLUSHED SEVERAL TIMES, HOWEVER, AIR WAS ASPIRATED. 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 11855898 ↗MalfunctionApr 16, 2021Fluid/Blood Leak; Fluid/Blood Leak
DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER INSERTING THE SHEATH INTO THE RIGHT FEMORAL VEIN AND PRIOR TO INSERTING ANY CATHETERS INTO THE SHEATH, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11680503 ↗MalfunctionAug 17, 2020Material Separation; Material Separation
THE SHEATH SEPARATED INTO TWO PIECES APPROXIMATELY 4CM DISTAL TO THE HUB WHEN BEING REMOVED FROM THE PATIENT AT THE END OF THE CASE. A HEMOSTAT WAS USED TO RETRIEVE THE DETACHED PORTION WITH NO CONSEQUENCES TO THE PATIENT. THE PHYSICIAN BELIEVES THE SHEATH WAS CUT BY PUTTING A SUTURE THROUGH THE SHAFT WHEN DOING A FIGURE 8 CLOSURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10414352 ↗MalfunctionJul 22, 2020Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
DURING A PROCEDURE, BLOOD WAS NOTED TO BE LEAKING FROM A TEAR IN THE SHAFT OF THE INTRODUCER. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10307104 ↗MalfunctionMar 12, 2019Gas/Air Leak; Gas/Air Leak
DURING THE PROCEDURE, AIR WAS ASPIRATED INTO THE SYRINGE THAT WAS CONNECTED TO THE EXTENSION PORT OF THE INTRODUCER. ANOTHER INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8411731 ↗MalfunctionMar 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn
DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE BODY OF THE INTRODUCER WAS TORN. WHEN REMOVING THE INTRODUCER, THE BODY WAS TORN 15 CM PROXIMAL TO THE TIP AND THE PROXIMAL PART OF THE SHEATH APPEARED STRETCHED IN A LONGITUDINAL DIRECTION. A PORTION OF THE SHEATH WAS REMOVED AND AN X-RAY CONFIRMED NO SHEATH MATERIAL REMAINED IN THE PATIENT. NO RESISTANCE WAS NOTED WHEN REMOVING, INSERTING, AND MANIPULATING THE CATHETER INTO THE SHEATH. THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8392053 ↗
Other INTRODUCER, CATHETER devices
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- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.