Fast-Cath™ 406362Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734023412), received between Jan 10, 2019 and Sep 15, 2025 — classified as 2 deaths, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Flaked” (1 report).

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.

• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE THE FAST-CATH 5FR SHEATH WAS NOTED TO BE FLIMSY AND THE INNER PART OF THE SHEATH WAS TOO LONG. THE TRANSITION FROM THE INNER TO THE SHEATH ITSELF WAS NOT TAPERED ENOUGH. THE SHEATH DAMAGED THE BLOOD VESSEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT IS STABLE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 23052586 ↗
• MalfunctionJan 11, 2024Flaked; Flaked

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE INTRODUCER WAS INTACT PRIOR TO INSERTION. HOWEVER, THERE WAS RESISTANCE WITH ROTATION DURING THE PROCEDURE. WHEN THE INTRODUCER WAS PULLED OUT, THE INTRODUCER WAS NOTED TO BE DEFORMED. THE SURFACE OF THE SHEATH WAS NOT SMOOTH AND THERE WAS FRITILLATION AFTER THE SHEATH WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498962 ↗
• InjuryAug 11, 2023Material Separation; Material Separation

  AT THE END OF AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A SECTION OF THE DEVICE DETACHED WHICH LED TO ABDOMINAL EMBOLIZATION. INTERVENTION WAS REQUIRED TO RETRIEVE THE DETACHED PORTION AND THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 17512780 ↗
• MalfunctionDec 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, BLOOD WAS LEAKING FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. NO INTERVENTION WAS NEEDED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9401187 ↗
• DeathJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 9680001-2018-00129, 9680001-2019-00004, 2182269-2019-00004, 3005334138-2019-00021, 3005334138-2019-00022, 3005334138-2019-00023. FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL INFARCTION AND EXPIRED. DURING THE PROCEDURE THE PATIENT WAS ANTICOAGULATED WITH HEPARIN AND THE ACT MONITORING WAS MADE IN 30-MINUTE INTERVALS. AFTER THE PROCEDURE THE PATIENT DID NOT WAKE UP FROM ANESTHESIA AND SUBSEQUENTLY EXPIRED. THERE WERE NO PERFORMANCE ISSUE WITH THE DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING THE CVA.

  Patient problems: Death; Myocardial Infarction; Stroke/CVA

  MAUDE report 8237195 ↗
• DeathJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 9680001-2018-00129, 9680001-2019-00004, 2182269-2019-00004, 3005334138-2019-00020, 3005334138-2019-00022, 3005334138-2019-00023. FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED A CEREBRAL INFARCTION AND EXPIRED. DURING THE PROCEDURE THE PATIENT WAS ANTICOAGULATED WITH APARINE AND THE ACT MONITORING WAS MADE IN 30-MINUTE INTERVALS. AFTER THE PROCEDURE THE PATIENT DID NOT WAKE UP FROM ANESTHESIA AND SUBSEQUENTLY EXPIRED. THERE WERE NO PERFORMANCE ISSUE WITH THE DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED REGARDING THE CVA.

  Patient problems: Death; Myocardial Infarction; Stroke/CVA

  MAUDE report 8237186 ↗