Fast-Cath™ 406968Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 05414734203562), received between Dec 6, 2018 and Sep 22, 2026 — classified as 84 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (58 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 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Gas/Air Leak

  During an atrial fibrillation procedure, air was aspirated from the Fast-Cath SL0 introducer when inserting the dilator and pulling the syringe. The introducer was replaced, and the procedure was completed with no adverse patient consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857252 ↗
• MalfunctionJan 27, 2026Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE WITH PULSED FIELD ABLATION, WHEN THE CATHETER WAS INSERTED, AIR ENTERED THE SYRINGE DURING FLUSHING. VISUAL INSPECTION REVEALED THAT THE HEMOSTATIC VALVE APPEARED LOOSE AND WIDENED. 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 24193599 ↗
• MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN AF PROCEDURE, AFTER INSERTING THE SHEATH INTO THE LEFT ATRIUM AND REMOVING THE DILATOR, BLOOD LEAKED FROM THE HEMOSTATIC VALVE PRIOR TO CATHETER 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 23865654 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTASIS VALVE AFTER THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM. THIS OCCURRED AFTER THE DILATOR WAS REMOVED PRIOR TO CATHETER 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 23824610 ↗
• MalfunctionDec 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM AND WHEN THE DILATOR WAS REMOVED, BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTATIC VALVE. THIS OCCURRED BEFORE THE CATHETER WAS INSERTED. 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 23824603 ↗
• MalfunctionNov 25, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR LEAKED FROM THE SHEATH. AFTER INSERTING THE SHEATH INTO THE HEART AND BEFORE INSERTING THE CATHETER OR TRANSSEPTAL NEEDLE, NEGATIVE PRESSURE WAS APPLIED, AND AIR WAS ASPIRATED. AIR ASPIRATION WAS PERFORMED SEVERAL TIMES, BUT THE AIR COULD NOT BE COMPLETELY REMOVED. 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 23650772 ↗
• MalfunctionNov 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKAGE WAS OBSERVED FROM THE VALVE IMMEDIATELY AFTER INSERTION INTO THE BODY. 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 23575345 ↗
• MalfunctionNov 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATIRUM. UPON INSERTION OF THE DIAGNOSTIC CATHETER INTO THE SHEATH, BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTASIS VALVE. 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 23458212 ↗
• MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED. THE SHEATH WAS INSERTED INTO THE HEART, AND A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE PRIOR TO SEPTAL PUNCTURE AND CATHETER INSERTION. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380271 ↗
• MalfunctionSep 9, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM. BEFORE INSERTING THE CATHETER AND THE TRANSSEPTAL PUNCTURE NEEDLE, ASPIRATION WAS PERFORMED FOR FLUSHING, AND AIR WAS ASPIRATED. DESPITE MULTIPLE ATTEMPTS, THE AIR COULD NOT BE COMPLETELY REMOVED. 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 23000762 ↗
• MalfunctionJul 29, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AF PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM. BEFORE INSERTING THE CATHETER OR TRANSSEPTAL NEEDLE, BLOOD LEAKAGE WAS NOTED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE ONLY DEVICE INSERTED DIRECTLY INTO THE HEMOSTATIC VALVE WAS THE INCLUDED DILATOR. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT. THERE WAS NO RESISTANCE WHEN INSERTING THE DILATOR. THE SHEATH AND DILATOR WERE INTEGRATED AND USED AS PER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22640109 ↗
• MalfunctionJul 9, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM, AND THE VIEWFLEX CATHETER WAS INSERTED INTO THE SHEATH. AFTER REMOVING THE CATHETER, AIR WAS ASPIRATED. AIR WAS ASPIRATED SEVERAL TIMES, BUT THE AIR COULD NOT BE COMPLETELY REMOVED. 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 22457521 ↗
• MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, WHEN THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND THE VIEWFLEX CATHETER WAS INSERTED INTO THE SHEATH, BLOOD LEAKAGE WAS NOTED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER. NO AIR ASPIRATION OR ENTRY INTO THE PATIENT¿S BODY WAS CONFIRMED. THE ONLY DEVICES INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WERE THE INCLUDED DILATOR AND VIEWFLEX CATHETER. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED WHEN THE INTRODUCER WAS REPLACED. NO PARTICULAR RESISTANCE WAS NOTED WHEN THE DILATOR WAS FIRST INSERTED INTO THE SHEATH HEMOSTASIS VALVE. THE DILATOR WAS PROPERLY INSERTED INTO THE SHEATH AND USED AS PER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22442441 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM. BEFORE SEPTAL PUNCTURE AND CATHETER INSERTION, WHEN NEGATIVE PRESSURE WAS APPLIED FOR FLUSHING, AIR WAS ASPIRATED, AND BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE ONLY PRODUCTS INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WAS THE INCLUDED DILATOR. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT. THERE WAS NO RESISTANCE WHEN INSERTING THE DILATOR. THE SHEATH AND DILATOR WERE INTEGRATED AND INSERTED AS PER THE PROCEDURE. THE HOSPITAL DISCARDED THE REPORTED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420115 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE HEART. AFTER THE VIEWFLEX CATHETER WAS INSERTED AND THEN REMOVED, BLOOD LEAKED FROM THE HEMOSTASIS VALVE WHEN NO CATHETER WAS INSERTED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE ONLY PRODUCTS INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WERE THE INCLUDED DILATOR AND VIEWFLEX CATHETER. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT. THERE WAS NO RESISTANCE WHEN INSERTING THE DILATOR. THE SHEATH AND DILATOR WERE INTEGRATED AND INSERTED AS PER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420093 ↗
• MalfunctionJul 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM, AND THE VIEWFLEX WAS INSERTED INTO THE SHEATH. WHEN THE VIEWFLEX WAS REMOVED TO INSERT THE ELECTRODE CATHETER, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED WITH A NON-ABBOTT 7F SHORT SHEATH, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411189 ↗
• MalfunctionJul 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND THE VIEWFLEX CATHETER WAS INSERTED INTO THE SHEATH, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. 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 22383740 ↗
• MalfunctionJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR ATRIAL FIBRILLATION, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH. THE SHEATH WAS REPLACED, HOWEVER THE SAME ISSUE OCCURRED. DUE TO IT BEING AT THE END OF THE PROCEDURE, THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350379 ↗
• MalfunctionJun 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR ATRIAL FIBRILLATION, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH. THE SHEATH WAS REPLACED, HOWEVER THE SAME ISSUE OCCURRED. DUE TO IT BEING AT THE END OF THE PROCEDURE, THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AGAIN. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22350374 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE HEART. AFTER THE VIEWFLEX CATHETER WAS INSERTED AND THEN REMOVED, BLOOD LEAKED FROM THE HEMOSTATIC VALVE WHEN NO CATHETER WAS INSERTED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE ONLY PRODUCTS INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WERE THE INCLUDED DILATOR AND VIEWFLEX CATHETER. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT. THERE WAS NO RESISTANCE WHEN INSERTING THE DILATOR. THE SHEATH AND DILATOR WERE INTEGRATED AND INSERTED AS PER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341608 ↗
• MalfunctionJun 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM. AFTER INSERTING AND REMOVING THE VIEWFLEX CATHETER INTO THE SHEATH, BLOOD BEGAN LEAKING FROM THE HEMOSTASIS VALVE WHEN INSERTING A 6F CATHETER. WHEN THE 6F CATHETER WAS REMOVED FROM THE SHEATH, THE BLOOD LEAK STOPPED, AND THE PROCEDURE WAS COMPLETED USING THE SAME SHEATH. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE ONLY PRODUCTS INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WERE THE INCLUDED DILATOR, VIEWFLEX CATHETER AND 6F CATHETER. THERE WAS NO RESISTANCE WHEN INSERTING THE DILATOR. THE SHEATH AND DILATOR WERE INTEGRATED AND INSERTED AS PER THE INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22340090 ↗
• MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A BLOOD LEAK OCCURRED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND THERE WAS NO PROBLEM WHEN INSERTING THE VIEWFLEX CATHETER, BUT WHEN IT WAS REPLACED WITH SNAKE CATHETER (6F 20-ELECTRODE CATHETER, JAPAN LIFELINE), A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS REPLACED WITH A NON-ABBOTT DEVICE (10F SHEATH MANUFACTURED BY TERUMO) 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 22328282 ↗
• MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WITH THE SHEATH IN THE RIGHT ATRIUM, THE VIEWFLEX CATHETER WAS INSERTED THROUGH THE SHEATH AND THEN REMOVED. HOWEVER, WHEN INSERTING THE 6F CATHETER INTO THE SHEATH, BLOOD BEGAN LEAKING FROM THE HEMOSTASIS VALVE. THE LEAK WAS MANAGED WITH TAPE, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE SHEATH AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE ONLY PRODUCTS INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WERE THE INCLUDED DILATOR, VIEWFLEX CATHETER AND 6F CATHETER. THERE WAS NO RESISTANCE WHEN INSERTING THE DILATOR. THE SHEATH AND DILATOR WERE INTEGRATED AND INSERTED AS PER THE INSTRUCTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22308426 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM. WHEN THE VIEW FLEX CATHETER WAS INSERTED INTO THE SHEATH, AIR WAS ASPIRATED FROM THE SIDE PORT, AND BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS REPLACED, BUT AGAIN WHEN THE VIEWFLEX CATHETER WAS INSERTED, AIR WAS ASPIRATED FROM THE SIDE PORT, AND BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SECOND SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302002 ↗
• MalfunctionJun 20, 2025Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM. WHEN THE VIEWFLEX CATHETER WAS INSERTED INTO THE SHEATH, AIR WAS ASPIRATED FROM THE SIDE PORT, AND BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS REPLACED, BUT AGAIN WHEN THE VIEWFLEX CATHETER WAS INSERTED, AIR WAS ASPIRATED FROM THE SIDE PORT, AND BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SECOND SHEATH WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301920 ↗