Fast-Cath™ 406849Recalls & reported problems

Summary

The FDA's MAUDE database contains 420 adverse event reports that list this exact device (DI 05414734203388), received between Sep 20, 2016 and Aug 24, 2026 — classified as 39 injuries, 381 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (164 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 420 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Gas/Air Leak

  During an atrial fibrillation procedure, an air leak was noted from the hemostasis valve on the Fast-Cath sheath after insertions and transseptal puncture. The Fast-Cath sheath was exchanged, and the procedure was completed with no adverse patient health consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50409042 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  During an atrial fibrillation procedure, ST elevation was noted during a guidewire exchange in the Fast-Cath sheath. Following difficult femoral venous access and transseptal puncture, the physician opted to switch to a stiffer guidewire to help advancement of the Agilis sheath through the kinked femoral vein. The Fast-Cath sheath was in the left atrium, and the guidewire was located in the left superior pulmonary vein. While withdrawing the guidewire, the patient developed ST elevation on the ECG. It was noted that the guidewire was not withdrawn with the dilator, which is alleged to have caused air bubbles that presumably got into the coronaries. The patient became hemodynamically unstable, pulse was lost, asystole on ECG and decrease in blood pressure. Akrinor was administered for hemodynamic support. CPR was performed for a few seconds. Heartbeat was obtained with only a rate of approximately 30 beats per minute. Emergent ventricular pacing was started and performed by an Inquiry catheter which was placed in the RV. The ST elevation was noted to gradually resolve over the next few minutes. The patient's hemodynamic condition slowly stabilized and ventricular pacing was able to

  Patient problems: Air Embolism; Arrhythmia; Low Blood Pressure/ Hypotension

  MAUDE report 50181583 ↗
• MalfunctionDec 30, 2025Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921930 ↗
• MalfunctionDec 23, 2025Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE SHEATH DURING ANALYSIS. DURING THE LAAO (LEFT ATRIAL APPENDAGE OCCLUSION) PROCEDURE, WHEN USING THE BRK NEEDLE AND FAST-CATH INTRODUCER FOR THE TRANSSEPTAL PUNCTURE, IT WAS NOTED THAT THE BRK NEEDLE COULD NOT PASS THROUGH INTRODUCER AFTER MULTIPLE ATTEMPTS. THE STYLET WAS USED, AND THE NEEDLE WAS NOT RESHAPED. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL PUNCTURE SITE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23885947 ↗
• MalfunctionDec 2, 2025Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE SHEATH DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23696222 ↗
• MalfunctionNov 19, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THERE WAS AN AIR LEAK. WHEN REMOVING AIR AFTER INSERTING THE DILATOR AND SHEATH THROUGH THE GUIDEWIRE, AIR WAS ASPIRATED INTERMITTENTLY. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593998 ↗
• MalfunctionNov 13, 2025Flaked; Flaked

  DURING THE ABLATION PROCEDURE, AFTER THE TRANSSEPTAL PUNCTURE THE NEEDLE WAS REMOVED AND A PIECE OF PLASTIC WAS SEEN AT THE TIP, PRESUMABLY SHEARED OFF FROM THE INSIDE OF THE DILATOR. THE SHEATH AND NEEDLE WERE BOTH REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547021 ↗
• MalfunctionNov 11, 2025Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS TO ADVISE OF A PUNCTURE FOUND IN THE TIP OF THE SHEATH DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23529430 ↗
• MalfunctionNov 3, 2025Flaked; Flaked

  DURING THE ATRIAL FIBRILLATION PROCEDURE, SKIVING OCCURRED. IT WAS DIFFICULT TO ADVANCE THE BRK NEEDLE FOR APPROXIMATELY THE LAST 5CM OF THE SHEATH. AFTER THE TRANSSEPTAL PUNCTURE, THE NEEDLE WAS REMOVED AND A PIECE OF PLASTIC WAS SEEN AT THE TIP, PRESUMABLY SHEARED OFF FROM THE INSIDE OF THE DILATOR. THE SHEATH AND NEEDLE WERE BOTH REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450766 ↗
• InjuryOct 30, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, ARRHYTHMIAS OCCURRED WHICH REQUIRED PACING AND CARDIOVERSION AND AN AIR EMBOLISM WAS DIAGNOSED. SHORTLY AFTER THE TRANSSEPTAL PUNCTURE WHILE THE SHEATH WAS POSITIONED AT THE LEFT ATRIUM, AN ST SEGMENT ELEVATION WAS OBSERVED. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED, AND AIR WAS DETECTED IN THE LEFT VENTRICULAR APEX AND LEFT VENTRICULAR OUTFLOW TRACT. THE SHEATH WAS THEN IMMEDIATELY REMOVED FROM THE LEFT ATRIUM. HEPARIN HAD ALREADY BEEN GIVEN RIGHT AFTER TRANSSEPTAL PUNCTURE. RAPID ATRIAL PACING AT A RATE OF 600 MS WAS PERFORMED TO SPEED UP THE AIR PASSAGE THROUGH THE CORONARY ARTERIES. PROGRESSIVE TO COMPLETE AV BLOCK WAS THEN PRESENT WHICH REQUIRED VENTRICULAR PACING FOR SEVERAL MINUTES. SHORTLY AFTER THAT, THE PATIENT DEVELOPED SEVERAL EPISODES OF POLYMORPHIC VENTRICULAR TACHYCARDIA (VT). SOME OF THE VT EPISODES WERE NOT SUSTAINED BUT TWO OF THESE WERE SUSTAINED AND REQUIRED EXTERNAL DIRECT CURRENT CARDIOVERSION. THE PATIENT WAS ADMITTED TO THE ICU FOR FURTHER TREATMENT. ONE HOUR POST-PROCEDURE, A CT SCAN WAS DONE AND NO AIR WAS OBSERVED. IT IS THOUGHT AN ISSUE WITH THE SHEATH VALVE CONTRIBUTED TO THE AIR EMBOLISM.

  Patient problems: Air Embolism; Arrhythmia

  MAUDE report 23423956 ↗
• MalfunctionOct 21, 2025Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  REPORT CREATED TO ADDRESS LEAK DISCOVERED DURING DEVICE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348374 ↗
• MalfunctionAug 21, 2025Flaked; Improper or Incorrect Procedure or Method; Flaked; Improper or Incorrect Procedure or Method

  THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE SHEATH DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868879 ↗
• MalfunctionAug 12, 2025Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE INTRODUCER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783541 ↗
• MalfunctionJul 30, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE AF PROCEDURE, IT WAS NOTED THAT THE INTRODUCER DREW AIR AFTER THE DEVICE WAS INSERTED INTO THE PATIENT. THE DEVICE WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22668874 ↗
• MalfunctionJul 10, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE PUNCTURE NEEDLE WOULD NOT PASS THROUGH THE SHEATH. THE SHEATH WAS THEN REMOVED, AND THE NEEDLE WAS ATTEMPTED TO PASS THROUGH THE SHEATH OUTSIDE THE BODY. DURING THIS, IT WAS FOUND THAT THE PUNCTURE NEEDLE HAD PUNCTURED THE SHEATH. THE SHEATH AND NEEDLE WERE REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. STYLET WAS USED, NEEDLE WAS NOT RESHAPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22471008 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING ATRIAL FIBRILLATION PROCEDURE, THE INTRODUCER LEAKED BLOOD. THE SHEATH WAS REPLACED TO COMPLETE THE PROCEDURE. THE PATIENT IS CURRENTLY RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22436201 ↗
• MalfunctionJul 2, 2025Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE SHEATH WAS PUNCTURED WHEN ATTEMPTING TO PERFORM TRANSSEPTAL PUNCTURE. PUNCTURE WAS ATTEMPTED USING A SHEATH, INTERATRIAL SEPTUM HEARTBEAT, AND NEEDLE. REPEATED ATTEMPTS DID NOT BREAK THROUGH THE INTERATRIAL SEPTUM. IT WAS FOUND THAT THE HEART RATE WAS A DISTORTED AND THE SHEATH HAD A PUNCTURE. THE NEEDLE WAS EXCHANGED, AND THE INTERATRIAL SEPTUM WAS THEN CROSSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384436 ↗
• MalfunctionJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH SIDE PORT WAS LEAKING BLOOD. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22351371 ↗
• MalfunctionJun 12, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THERE WAS AN AIR LEAK FROM THE SHEATH. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22193867 ↗
• MalfunctionJun 4, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR ATRIAL FIBRILLATION, THE SHEATH WAS INSERTED INTO THE PATIENT AND DURING ASPIRATION, IT WAS NOTED THE VALVE WAS DRAWING AIR. 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 22140262 ↗
• MalfunctionMay 30, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RADIOFREQUENCY ABLATION OF SUPRAVENTRICULAR TACHYCARDIA, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE GUIDEWIRE WAS INSERTED AFTER PUNCTURING FOR FEMORAL VEIN ACCESS. AFTER INSERTING THE ATRIAL SEPTAL PUNCTURE SHEATH ALONG THE GUIDEWIRE, THE VALVE OF THE SHEATH WAS SLOWLY LEAKING BLOOD. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE EFFECTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115932 ↗
• MalfunctionMay 8, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PREMATURE VENTRICULAR CONTRACTION CASE, THE SHEATH WAS INTERMITTENTLY ASPIRATING AIR WHILE IN THE LEFT VENTRICULAR OUTFLOW TRACT. ANOTHER SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985552 ↗
• MalfunctionApr 22, 2025Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE INTRODUCER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884205 ↗
• MalfunctionFeb 21, 2025Flaked; Flaked

  THIS REPORT IS TO ADVISE OF SKIVING FOUND IN THE SHEATH DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21437698 ↗
• InjuryJan 22, 2025Gas/Air Leak; Gas/Air Leak

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, AN AIR EMBOLISM OCCURRED. 5-6ML OF AIR WAS SUCCESSFULLY EXTRACTED FROM THE LEFT VENTRICLE. AN ACIST-PUMP WAS USED AS WELL. THE PATIENT REMAINED STABLE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Air Embolism

  MAUDE report 21210779 ↗