Fast-Cath™ 406333Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734203876), received between Sep 13, 2021 and Nov 10, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A LEAK FROM THE HEMOSTASIS VALVE WAS NOTED. THEREFORE, IT WAS REMOVED AND THE INTRODUCER WAS REPLACED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511465 ↗
• MalfunctionJan 20, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE SHEATH WAS INSERTED INTO THE PATIENT, AND BLOOD LEAKED FROM THE HEMOSTATIC VALVE OF THE SHEATH. THIS OCCURRED BEFORE THE CATHETER OR SEPTAL PUNCTURE NEEDLE WAS INSERTED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED DEVICE. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED FOR SHEATH REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16218554 ↗
• MalfunctionFeb 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  MANUFACTURER REF# 3005334138-2022-00072. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, BLOOD WAS LEAKING FROM THE HEMOSTASIS VALVES OF THE SHEATH, AFTER INSERTING THE SHEATH INTO A PATIENT PRIOR TO INSERTING CATHETERS. THE SHEATH SET WAS REPLACED BUT BLOOD LEAK WAS NOTED AGAIN. 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 13616364 ↗
• MalfunctionFeb 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURER REF# 3005334138-2022-00073. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A BLOOD WAS NOTED FROM THE HEMOSTASIS VALVES OF THE SHEATH. THE SHEATH SET WAS REPLACED WHICH DID NOT RESOLVE THE ISSUE. 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 13616360 ↗
• MalfunctionDec 28, 2021Gas/Air Leak; Gas/Air Leak

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, AIR WAS ASPIRATED INTO THE DEVICE WHEN ATTEMPTING TO FLUSH. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13094147 ↗
• MalfunctionSep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE, A BLOOD LEAK 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460269 ↗