Fast-Cath™ 406955Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05414734203999), received between Aug 30, 2018 and Dec 20, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2023Gas/Air Leak; Gas/Air Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AIR WAS ASPIRATED FROM THE CONNECTOR DURING PUNCTURE. 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 18365302 ↗
• MalfunctionDec 22, 2021Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AN AIR LEAK WAS NOTED WHEN ASPIRATING FROM EACH PORT WITH A SYRINGE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059900 ↗
• MalfunctionJun 2, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. 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 11919583 ↗
• MalfunctionAug 14, 2020Difficult to Insert; Difficult to Insert

  DURING A PROCEDURE, RESISTANCE WAS NOTED WHEN INSERTING THE INTRODUCER AND THE DILATOR ASSEMBLY INTO THE FEMORAL VEIN. UPON REMOVAL OF THE DEVICE, CRACKS WERE NOTED AT THE TIP OF THE DILATOR. IT WAS NOTED THERE WAS A GAP BETWEEN THE DILATOR AND THE TIP OF THE INTRODUCER TRANSITION ZONE, AND INCOMPATIBILITY WITH THE GUIDEWIRE AND THE DILATOR. THREE ADDITIONAL PUNCTURES AND THREE REPLACEMENT INTRODUCERS WERE REQUIRED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10407962 ↗
• MalfunctionAug 30, 2018Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AIR ENTERED FROM THE HEMOSTASIS VALVE WHEN THE INTRODUCER WAS PLACED IN THE PATIENT AND FLUSHED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832552 ↗