Fast-Cath™ 406354Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734013000), received between Jul 25, 2019 and Jun 7, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  THE PATIENT BEGAN TO RECEIVE ECMO CONTINUOUS TREATMENT TO MAINTAIN CARDIOPULMONARY FUNCTION, AND THE SUPERFICIAL FEMORAL ARTERY COLLATERAL OF THE RIGHT LOWER EXTREMITY WAS IMPLANTED WITH A FAST-CATH HEMOSTASIS INTRODUCER. BLOOD WAS FLOWING OUT FROM THE HEAD OF THE SHEATH. AFTER INSPECTION, THE WHITE PART OF THE SHEATH WAS FOUND TO BE CRACKED. IMMEDIATELY REPLACED A NEW SHEATH, RE-INSERTED THE CATHETER INTO THE SUPERFICIAL FEMORAL ARTERY SIDE OF THE RIGHT LOWER EXTREMITY. THERE WAS A SMALL AMOUNT OF BLEEDING DURING THE CATHETERIZATION PROCESS, WHICH CAUSED SECONDARY INJURY TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17079825 ↗
• MalfunctionNov 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE HEMOSTASIS VALVE WAS LEAKING BLOOD. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9362382 ↗
• InjuryJul 25, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE WITH THE INTRODUCER, THE PATIENT EXPERIENCED BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 8828057 ↗