Fast-Cath™ 406307Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734203838), received between Mar 2, 2021 and Oct 3, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  WHEN THE PROCEDURE WAS COMPLETED, A BLOOD LEAK WAS NOTED FROM THE SHEATH WHEN REMOVED FROM THE PUNCTURE SITE. IT WAS NOT THE HEMOSTATIC VALVES OR FLASHPORTS. WHEN CHECKED, HOLES WERE FOUND IN THE BODY OF THE SHEATH. IT IS UNCLEAR WHEN THE HOLES WERE CREATED. THERE WAS NO RESISTANCE AT THE TIME OF INSERTION OF THE SHEATH. 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 17860221 ↗
• MalfunctionOct 19, 2022Fluid/Blood Leak; Gas/Air Leak; Fluid/Blood Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE SIDEPORT OF THE SHEATH. 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 15631259 ↗
• MalfunctionNov 2, 2021Fracture; Material Separation; Fracture; Material Separation

  DURING DEVICE PREPARATION FOR A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE, PRIOR TO INSERTING THE SHEATH INTO A PATIENT, ONE OF THE PORTS WAS FRACTURED DISTAL OF HEMOSTASIS VALVE. 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 12739628 ↗
• MalfunctionMar 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. AFTER PLACING THE SHEATH INTO THE PATIENT, BUT PRIOR TO INSERTING INTO CATHETERS, BLOOD WAS LEAKING FROM THE HEMOSTASIS VALVE OF THE GREEN-COLORED PORT 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 11402182 ↗