Fast-Cath™ 406112Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05414734013918), received between Sep 13, 2021 and Aug 13, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood 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. How this data works · Data updated Oct 13, 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.

• InjuryAug 13, 2025Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem; Material Puncture/Hole; Adverse Event Without Identified Device or Use Problem

  DURING A TAVI PROCEDURE IN THE RIGHT FEMORAL ARTERY, A PERFORATION OCCURRED REQUIRING A TRANSFUSION ALONG WITH FURTHER SURGICAL INTERVENTION.

  Patient problems: Cardiac Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22794378 ↗
• InjuryApr 9, 2024Material Separation; Material Separation

  DURING THE PROCEDURE, THE TIP OF THE SHEATH WAS SHEARED OFF. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19075476 ↗
• InjuryAug 16, 2022Difficult to Insert; Difficult to Insert

  DURING THE PROCEDURE, THE DEVICE WAS INSERTED FROM THE RIGHT GROIN TO THE FEMORAL VEIN. FOLLOWING REMOVAL OF THE DILATOR, THE CANNULA WAS SWOLLEN IN TWO PLACES. ANOTHER DEVICE WAS USED AND INSERTED THROUGH AN ADDITIONAL PUNCTURE SITE TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15231872 ↗
• MalfunctionSep 24, 2021Material Separation; Material Separation

  DURING AN ABLATION PROCEDURE, THE DISTAL PORTION THE SHEATH DETACHED FOLLOWING INSERTION INTO THE FEMORAL VEIN DURING THE ACCESS PROCESS. THE PIECE BROKE DUE TO A NEEDLE BEING INADVERTENTLY PUSHED THRU THE SIDE WALL OF THE SHEATH AND THEN PULLED. THE DETACHED PORTION WAS RETRIEVED USING AN ENDOMYOCARDIAL BIOPSY FORCEPS THRU A LARGER 14F SHEATH. A REPLACEMENT SHEATH WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body Embolism

  MAUDE report 12527147 ↗
• MalfunctionSep 20, 2021Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURER REPORT NUMBER: 3005334138-2021-00557. DURING PERIPHERAL PROCEDURE, A BLOOD LEAK OCCURRED. AFTER PLACING THE GUIDEWIRE, BLOOD WOULD LEAK FROM THE INTRODUCER. THE SHEATH WAS REPLACED BUT THE SAME ISSUE OCCURRED, HOWEVER, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SECOND SHEATH WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494730 ↗
• MalfunctionSep 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  RELATED MANUFACTURER REPORT NUMBER: DURING PERIPHERAL PROCEDURE, A BLOOD LEAK OCCURRED. AFTER PLACING THE GUIDEWIRE, BLOOD WOULD LEAK FROM THE INTRODUCER. THE SHEATH WAS REPLACED BUT THE SAME ISSUE OCCURRED, HOWEVER, THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SECOND SHEATH WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12462960 ↗