Fast-Cath™ 406705Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734216982), received between Jul 10, 2018 and Oct 8, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionOct 8, 2024Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE PATIENT, AND AIR WAS ASPIRATED WHEN BLOOD WAS DRAWN FROM THE PORT. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396813 ↗
• InjuryNov 1, 2023Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE TIP OF THE SHEATH WAS FOUND TO BE FRAYED AND COULD NOT BE INSERTED. AN ADDITIONAL ACCESS SITE WAS NEEDED TO REPLACE THE SHEATH AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18046507 ↗
• MalfunctionMar 28, 2022Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE HEMOSTASIS VALVE DETACHED. THE PROCEDURE WAS COMPLETED AND UPON REMOVAL OF THE SHEATH, IT WAS NOTED THAT THE HEMOSTASIS VALVE HAD DETACHED FROM THE TIP. FLUOROSCOPY WAS PERFORMED, WHICH REVEALED THE HEMOSTASIS VALVE REMAINED IN THE PATIENT. THE DETACHED PORTION WAS REMOVED USING A FORCEPS FROM THE SAME SIDE OF THE RIGHT INGUINAL REGION, BUT IT DID NOT REACH, AND THE GUIDEWIRE PRECEDED FROM THE CONTRALATERAL SIDE, AND REMOVAL WAS SUCCESSFUL WITH A SNARE. THERE WERE NO CONSEQUENCES TO THE PATIENT. THE CAUSE OF THE DETACHMENT WAS LIKELY DUE TO EXCESSIVE TORSIONAL FORCE APPLIED TO THE SHEATH.

  Patient problems: Foreign Body Embolism; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13928891 ↗
• InjuryJul 10, 2018Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE THE DISTAL PORTION OF THE SHEATH DETACHED WITHIN THE PATIENT. THE SHEATH DETACHED AT THE HUB AND TRAVELED INTO THE PATIENT'S RIGHT ATRIUM. A SNARE WAS USED TO RETRIEVE THE DETACHED PORTION AND FLUOROSCOPY CONFIRMED SUCCESSFUL REMOVAL. THE PATIENT WAS STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7674064 ↗