Fast-Cath™ 406183Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734014458), received between Aug 21, 2019 and Mar 19, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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.

• MalfunctionMar 19, 2024Gas/Air Leak; Gas/Air Leak

  DURING A PERSISTENT ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED. AFTER INSERTION INTO THE HEART BUT BEFORE INSERTING THE CATHETER, AIR WAS ASPIRATED INTO THE SYRINGE. AIR ASPIRATION WAS PERFORMED SEVERAL TIMES WITH NO RESOLUTION. 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 18935674 ↗
• MalfunctionAug 11, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED WHEN THE SHEATH WAS INSERTED INTO THE PATIENT AND AIR WAS REMOVED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15210625 ↗
• MalfunctionJul 22, 2022Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE JOINT BETWEEN THE SHEATH TUBE AND SHEATH HUB SEPARATED. UPON REMOVAL OF THE SHEATH FROM THE PATIENT AND ATTEMPTING TO PULL OUT THE SHEATH FROM THE RIGHT INGUINAL REGION, THE JOINT BETWEEN THE SHEATH TUBE AND SHEATH HUB SEPARATED. 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 15087004 ↗
• MalfunctionAug 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  BLOOD WAS LEAKING FROM THE HEMOSTASIS VALVE DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, PRIOR TO INSERTION OF CATHETERS. THE SHEATH SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8914890 ↗