Fast-Cath™ 406840Recalls & reported problems
St. Jude Medical, Inc. · Transseptal Guiding Introducer · Class 2
Quick summary
This St. Jude Medical Fast-Cath transseptal introducer is a guiding sheath used in heart procedures. Its 102 FDA reports include 5 injuries and 2 deaths, and often describe the sheath flaking and shedding small plastic particles, along with holes, leaks, and difficult insertion. Some reports mention a hole in the heart wall. Reports fell to 2 in the last 12 months from 8 before. No recalls name this device.
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
- 102
- Deaths reported
- 2
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 05414734203340), received between Aug 30, 2018 and Dec 30, 2025 — classified as 2 deaths, 5 injuries, 95 malfunctions.
The most frequently reported specific device problem is “Flaked” (50 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
- Flaked50
- Material Puncture/Hole19
- Fluid/Blood Leak13
- Difficult to Insert11
- Adverse Event Without Identified Device or Use Problem4
- Material Separation4
- Gas/Air Leak3
- Improper or Incorrect Procedure or Method3
Patient problems
- No Clinical Signs, Symptoms or Conditions63
- No Consequences Or Impact To Patient32
- Cardiac Perforation5
- Death2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Flaked; Flaked
DURING THE ATRIAL FIBRILLATION, EVIDENCE OF SKIVING WAS OBSERVED. AFTER THE NEEDLE FOR THE TRANSSEPTAL PUNCTURE HAD BEEN INSERTED THROUGH THE DILATOR OF THE SHEATH AND WITHDRAWN, THE GUIDEWIRE COULD NO LONGER BE ADVANCED THROUGH THE DILATOR. AFTER REMOVING THE SHEATH AND DILATOR FROM THE PATIENT, THE PHYSICIAN ATTEMPTED TO FORCE THE WIRE THROUGH THE DILATOR AGAIN, AND SMALL PLASTIC PARTICLES EMERGED. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927136 ↗MalfunctionNov 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
DURING THE PROCEDURE, THE TRANSSEPTAL PUNCTURE WAS PERFORMED AND AFTER INSERTING THE INTRODUCER, IT WAS NOTED THAT THE VALVE AT THE BACK OF THE DILATOR WAS LEAKING. 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 23596997 ↗MalfunctionSep 12, 2025Material Puncture/Hole; Material Puncture/Hole
THIS REPORT IS TO ADVISE OF A PUNCTURE FOUND IN THE SHEATH DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042629 ↗MalfunctionSep 9, 2025Difficult to Insert; Difficult to Insert
THIS REPORT IS TO ADVISE OF SKIVING NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004211 ↗MalfunctionAug 21, 2025Difficult to Insert; Difficult to Insert
THIS REPORT IS TO ADVISE OF SKIVING THAT WAS NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22860468 ↗MalfunctionAug 12, 2025Flaked; Flaked
THIS REPORT IS TO ADVISE OF SKIVING NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22781357 ↗MalfunctionMar 20, 2025Flaked; Flaked
DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SKIVING OCCURRED. THE INTRODUCER AND NEEDLE WERE PREPARED AND FLUSHED PRIOR TO USE. THE INTRODUCER WAS INSERTED INTO THE RIGHT FEMORAL VEIN WITHOUT ISSUE. THE NEEDLE WAS PLACED THROUGH THE INTRODUCER WHEN RESISTANCE WAS FELT. THE TRANSSEPTAL WAS PERFORMED AND THE INTRODUCER WAS PLACED INTO THE LEFT ATRIUM. THE NEEDLE WAS REMOVED AND WHILE ATTEMPTING TO ADVANCE THE GUIDEWIRE THROUGH THE INTRODUCER, RESISTANCE WAS NOTED. THE INTRODUCER WAS REMOVED FROM THE PATIENT AND FLUSHED AND A PIECE OF WHITE PLASTIC CAME OUT. THE PROCEDURE WAS ABORTED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE STYLET WAS USED AND THE NEEDLE WAS NOT RESHAPED. THE PHYSICIAN BELIEVES THAT DUE TO THE ANGLE THAT THE SHEATH ENTERED THE FEMORAL VEIN, THE NEEDLE FOLLOWED A COURSE THAT CAUSED IT TO BEND AND SCRAPE THE INSIDE OF THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21651701 ↗MalfunctionJan 21, 2025Gas/Air Leak; Gas/Air Leak
DURING A PULMONARY VEIN ISOLATION PROCEDURE, IT WAS NOTED THAT THE SHEATH DREW AIR DURING ASPIRATION. 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 21196504 ↗MalfunctionNov 18, 2024Flaked; Improper or Incorrect Procedure or Method; Flaked; Improper or Incorrect Procedure or Method
DURING AN ATRIAL FIBRILLATION PROCEDURE, RESISTANCE WAS FELT WHEN THE INTRODUCER WAS INSERTED IN THE PATIENT. AFTER REMOVING THE INTRODUCER, SKIVING WAS OBSERVED. THE INTRODUCER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. A STYLET WAS NOT USED, WHICH GOES AGAINST THE INTRODUCER INSTRUCTIONS FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20703147 ↗InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4, A PERICARDIAL EFFUSION OCCURRED REQUIRING A PERICARDIOCENTESIS AND PROTAMINE. DURING TRANSSEPTAL PUNCTURE, THE SHEATH CROSSED THE INTERATRIAL SEPTUM WITHOUT USE OF THE NEEDLE. DUE TO THE PATIENT'S ANATOMY, THE TRANSSEPTAL PUNCTURE HEIGHT WAS ONLY 2.7CM, HOWEVER, THIS WAS THE MAXIMAL HEIGHT THAT COULD BE ACHIEVED. THE PUNCTURE SITE WAS DEEMED SAFE BY THE PHYSICIAN, SO THE PROCEDURE WAS CONTINUED. THE STEERABLE GUIDE CATHETER (SGC) AND CLIP DELIVERY SYSTEM (CDS) WERE INSERTED AND PLACED ON THE VALVE WITHOUT ISSUES. HOWEVER, WHILE EVALUATING THE IMPLANT, THE SYSTOLIC PRESSURE WENT FROM APPROXIMATELY 90 TO 50. A LARGE PERICARDIAL EFFUSION WAS OBSERVED BEHIND THE RIGHT VENTRICLE (RV). THE CLIP WAS DEPLOYED AND PERICARDIOCENTESIS WAS PERFORMED. THE SYSTOLIC PRESSURE RETURNED TO NORMAL, AND PROTAMINE WAS ADMINISTERED. THE PATIENT LEFT THE OPERATING ROOM INTUBATED AND STABLE. THE PHYSICIAN SUSPECTED THE SHEATH CAUSED THE PERICARDIAL EFFUSION DURING TRANSSEPTAL PUNCTURE OR DURING INTERACTION WITH THE RIGHT ATRIAL APPENDAGE WHEN THE TRANSSEPTAL SYSTEM WAS BEING PLACED IN THE SVC.
Patient problems: Cardiac Perforation
MAUDE report 20588643 ↗MalfunctionJul 16, 2024Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert
RELATED MANUFACTURING REF: 3008452825-2024-00403. DURING AN ATRIAL TACHYCARDIA PROCEDURE, DEFLECTION AND INSERTION DIFFICULTIES WERE NOTED WHICH CAUSED A DELAY IN PROCEDURE. FOLLOWING INSERTION INTO THE PATIENT, THE INTRODUCER WOULD NOT ROTATE AND THE AUTO LOCK DID NOT FUNCTION. ANOTHER INTRODUCER WAS THEN INSERTED INTO THE PATIENT WITH SOME RESISTANCE. UPON REMOVAL FROM THE PATIENT, IT WAS NOTED THAT THE TIP WAS FRAYED. A THIRD INTRODUCER WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19756404 ↗MalfunctionMar 25, 2024Flaked; Flaked
DURING TRANSSEPTAL PUNCTURE OF A WOLFF-PARKINSON-WHITE SYNDROME PROCEDURE, WITH A FAST-CATH TRANSSEPTAL INTRODUCER AND NON-ABBOTT NEEDLE (MEDTRONIC), THAT WAS RESHAPED, THERE WAS SKIVING. IT WAS ATTEMPTED TO FLUSH CONTRAST THROUGH THE NEEDLE WHICH WAS INSIDE THE FAST-CATH TRANSSEPTAL INTRODUCER AGAINST THE SEPTUM, BUT THE CONTRACT COULD NOT BE FLUSHED. THE NEEDLE WAS REMOVED, AND IT WAS FOUND THAT SOME OF THE FAST-CATH TRANSSEPTAL INTRODUCER MATERIAL WAS CLOGGING THE NEEDLE TIP. THE FAST-CATH TRANSSEPTAL INTRODUCER AND NON-ABBOTT NEEDLE (MEDTRONIC) NEEDLE WERE REPLACED AND TRANSSEPTAL PUNCTURE WAS SUCCESSFUL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18971071 ↗MalfunctionOct 30, 2023Material Puncture/Hole; Material Puncture/Hole
DURING THE PROCEDURE, THE NEEDLE PIERCED THROUGH THE SHEATH CURVE WHEN ATTEMPTING TRANSSEPTAL PUNCTURE. THE NEEDLE AND SHEATH WERE EXCHANGED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18030243 ↗MalfunctionSep 18, 2023Flaked; Flaked
THIS REPORT IS TO ADVISE OF SKIVING NOTED DURING ANALYSIS OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17764171 ↗MalfunctionSep 11, 2023Flaked; Flaked
RELATED MANUFACTURING REF: 3005334138-2023-00408, 3005334138-2023-00409, 3005334138-2023-00410, 3005334138-2023-00411, 3005334138-2023-00412, 3005334138-2023-00413, 3005334138-2023-00414 DURING EIGHT ATRIAL FIBRILLATION PROCEDURES, SKIVING OCCURRED. WHEN INSERTING THE TRANSSEPTAL NEEDLE FOR PUNCTURE WITH THE STYLET, A LITTLE PIECE OF PLASTIC WAS RIBBED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726730 ↗MalfunctionSep 11, 2023Flaked; Flaked
RELATED MANUFACTURING REF: 3005334138-2023-00408, 3005334138-2023-00409, 3005334138-2023-00410, 3005334138-2023-00411, 3005334138-2023-00412, 3005334138-2023-00413, 3005334138-2023-00415 DURING EIGHT ATRIAL FIBRILLATION PROCEDURES, SKIVING OCCURRED. WHEN INSERTING THE TRANSSEPTAL NEEDLE FOR PUNCTURE WITH THE STYLET, A LITTLE PIECE OF PLASTIC WAS RIBBED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726726 ↗MalfunctionSep 11, 2023Flaked; Flaked
RELATED MANUFACTURING REF: 3005334138-2023-00408, 3005334138-2023-00409, 3005334138-2023-00410, 3005334138-2023-00411, 3005334138-2023-00412, 3005334138-2023-00414, 3005334138-2023-00415. DURING EIGHT ATRIAL FIBRILLATION PROCEDURES, SKIVING OCCURRED. WHEN INSERTING THE TRANSSEPTAL NEEDLE FOR PUNCTURE WITH THE STYLET, A LITTLE PIECE OF PLASTIC WAS RIBBED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726724 ↗MalfunctionSep 11, 2023Flaked; Flaked
RELATED MANUFACTURING REF: 3005334138-2023-00408, 3005334138-2023-00409, 3005334138-2023-00410, 3005334138-2023-00411, 3005334138-2023-00413, 3005334138-2023-00414, 3005334138-2023-00415. DURING EIGHT ATRIAL FIBRILLATION PROCEDURES, SKIVING OCCURRED. WHEN INSERTING THE TRANSSEPTAL NEEDLE FOR PUNCTURE WITH THE STYLET, A LITTLE PIECE OF PLASTIC WAS RIBBED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726719 ↗MalfunctionSep 11, 2023Flaked; Flaked
RELATED MANUFACTURING REF: 3005334138-2023-00408, 3005334138-2023-00409, 3005334138-2023-00410, 3005334138-2023-00412, 3005334138-2023-00413, 3005334138-2023-00414, 3005334138-2023-00415. DURING EIGHT ATRIAL FIBRILLATION PROCEDURES, SKIVING OCCURRED. WHEN INSERTING THE TRANSSEPTAL NEEDLE FOR PUNCTURE WITH THE STYLET, A LITTLE PIECE OF PLASTIC WAS RIBBED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726714 ↗MalfunctionSep 11, 2023Flaked; Flaked
RELATED MANUFACTURING REF: 3005334138-2023-00408, 3005334138-2023-00409, 3005334138-2023-00411, 3005334138-2023-00412, 3005334138-2023-00413, 3005334138-2023-00414, 3005334138-2023-00415. DURING EIGHT ATRIAL FIBRILLATION PROCEDURES, SKIVING OCCURRED. WHEN INSERTING THE TRANSSEPTAL NEEDLE FOR PUNCTURE WITH THE STYLET, A LITTLE PIECE OF PLASTIC WAS RIBBED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726711 ↗MalfunctionSep 11, 2023Flaked; Flaked
RELATED MANUFACTURING REF: 3005334138-2023-00408, 3005334138-2023-00410, 3005334138-2023-00411, 3005334138-2023-00412, 3005334138-2023-00413, 3005334138-2023-00414, 3005334138-2023-00415. DURING EIGHT ATRIAL FIBRILLATION PROCEDURES, SKIVING OCCURRED. WHEN INSERTING THE TRANSSEPTAL NEEDLE FOR PUNCTURE WITH THE STYLET, A LITTLE PIECE OF PLASTIC WAS RIBBED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726710 ↗MalfunctionSep 11, 2023Flaked; Flaked
RELATED MANUFACTURING REF: 3005334138-2023-00409, 3005334138-2023-00410, 3005334138-2023-00411, 3005334138-2023-00412, 3005334138-2023-00413, 3005334138-2023-00414, 3005334138-2023-00415. DURING EIGHT ATRIAL FIBRILLATION PROCEDURES, SKIVING OCCURRED. WHEN INSERTING THE TRANSSEPTAL NEEDLE FOR PUNCTURE WITH THE STYLET, A LITTLE PIECE OF PLASTIC WAS RIBBED OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17726708 ↗MalfunctionSep 6, 2023Flaked; Flaked
THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE INTRODUCER DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17695108 ↗MalfunctionAug 31, 2023Flaked; Flaked
THIS REPORT IS TO ADVISE OF THE DILATOR SKIVING NOTED DURING ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17662018 ↗MalfunctionAug 30, 2023Flaked; Improper or Incorrect Procedure or Method; Flaked; Improper or Incorrect Procedure or Method
DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE NEEDLE WAS NOT ABLE TO PASS THROUGH THE SHEATH WITHOUT PRESSURE. IF PUSHED WITH PRESSURE THE BRK NEEDLE PEELED OF A LITTLE PLASTIC PIECE FROM THE SHEATH. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL PUNCTURE SITE WAS REQUIRED. NO STYLET WAS USED AND THE NEEDLE WAS NOT RESHAPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17652065 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.