Fast-Cath™ 406123Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734014038), received between Aug 17, 2018 and Feb 9, 2023 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionFeb 9, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, IT WAS NOTED THAT THERE WERE SMALL HOLES IN THE SHEATH DURING FEMORAL VEIN ACCESS. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16337243 ↗
• MalfunctionJan 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE WHEN THE NON ABBOTT CATHETER WAS EXCHANGED FOR AN ABLATOR CATHETER. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170045 ↗
• MalfunctionJan 29, 2019Material Perforation; Material Perforation

  THE FAST-CATH HEMOSTASIS INTRODUCER WAS BENT DURING INSERTION IN THE FEMORAL VEIN. AN ABLATION CATHETER WAS INSERTED INTO THE SHEATH AND THE CATHETER PUNCTURED THROUGH THE SHEATH WALL. THE SHEATH WAS REMOVED AND PROCEDURE WAS COMPLETED BY PERFORMING AN ADDITIONAL FEMORAL PUNCTURE AND INSERTING AN SLO. THERE WERE NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8287870 ↗
• InjuryAug 17, 2018Material Separation; Material Separation

  THE FAST-CATH HEMOSTASIS INTRODUCER WAS ADVANCED THROUGH THE RIGHT FEMORAL VEIN. WHEN THE OPERATOR TWISTED THE HEMOSTASIS VALVE ON THE INTRODUCER TO MOVE IT INTO PLACE, THE VALVE SHEARED OFF THE INTRODUCER JUST DISTALLY TO THE END OF THE VALVE, LEAVING THE REMAINDER OF THE INTRODUCER WITHIN THE VEIN. IN ORDER TO RETRIEVE THE REMAINDER OF THE INTRODUCER, A SMALL INCISION WAS MADE IN THE GROIN AND A SET OF SURGICAL FORCEPS WAS UTILIZED TO GAIN TRACTION OF THE INTRODUCER. THE REMAINDER WAS RETRIEVED, AND THE PROCEDURE WAS CONTINUED USING A NEW SHEATH. THE PATIENT INFORMATION IS NOT AVAILABLE DUE TO HOSPITAL PRIVACY POLICY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7793606 ↗