Fast-Cath™ 406116Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05414734013970), received between Feb 3, 2022 and Feb 25, 2022 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER WHEN THE GUIDEWIRE WAS ADVANCED THROUGH THE VALVE. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13603351 ↗
• MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. WHEN THE PROVIDED WIRE WAS ADVANCED THROUGH THE SHEATH VALVE, A CONTINUAL LEAK WAS NOTED. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591538 ↗
• MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. WHEN THE PROVIDED WIRE WAS ADVANCED THROUGH THE SHEATH VALVE, A CONTINUAL LEAK WAS NOTED. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591408 ↗
• MalfunctionFeb 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. WHEN THE PROVIDED WIRE WAS ADVANCED THROUGH THE SHEATH VALVE, A CONTINUAL LEAK WAS NOTED. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560140 ↗
• MalfunctionFeb 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER WHEN THE GUIDEWIRE WAS ADVANCED THROUGH THE VALVE. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543528 ↗
• MalfunctionFeb 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER WHEN THE GUIDEWIRE WAS ADVANCED THROUGH THE VALVE. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538121 ↗
• MalfunctionFeb 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER WHEN THE GUIDEWIRE WAS ADVANCED THROUGH THE VALVE. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538115 ↗
• MalfunctionFeb 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER WHEN THE GUIDEWIRE WAS ADVANCED THROUGH THE VALVE. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538112 ↗
• MalfunctionFeb 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE WHEN THE WIRE IS ADVANCED THROUGH THE VALVE. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446192 ↗
• MalfunctionFeb 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE WHEN THE WIRE IS ADVANCED THROUGH THE VALVE. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446116 ↗
• MalfunctionFeb 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A FLUID LEAK WAS NOTED FROM THE HEMOSTASIS VALVE WHEN THE WIRE WAS ADVANCED THROUGH THE VALVE. THE PROCEDURE CONTINUED WITHOUT EXCHANGING THE SHEATH WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13444917 ↗