Fast-Cath™ 406107Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05414734013819), received between Feb 7, 2020 and Oct 30, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Separation” (9 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT THE SIDEPORT DETACHED FOR A LEAVE-IN SWAN PROCEDURE. IT WAS REPORTED THAT THE STAFF WERE ATTEMPTING TO INFUSE MEDICATIONS THROUGH THE SIDEPORT OF THE 7F SHEATH WITH A 7F SWAN IN PLACE. THE SHEATH AND THE SWAN WERE REPLACED TO RESOLVE THE ISSUE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432978 ↗
• MalfunctionOct 30, 2025Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT THE SIDEPORT DETACHED FOR A LEAVE-IN SWAN PROCEDURE. IT WAS REPORTED THAT THE STAFF WERE ATTEMPTING TO INFUSE MEDICATIONS THROUGH THE SIDEPORT OF THE 7F SHEATH WITH A 7F SWAN IN PLACE. THE SHEATH AND THE SWAN WERE REPLACED TO RESOLVE THE ISSUE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432969 ↗
• MalfunctionOct 30, 2025Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT THE SIDEPORT DETACHED FOR A LEAVE-IN SWAN PROCEDURE. IT WAS REPORTED THAT THE STAFF WERE ATTEMPTING TO INFUSE MEDICATIONS THROUGH THE SIDEPORT OF THE 7F SHEATH WITH A 7F SWAN IN PLACE. THE SHEATH AND THE SWAN WERE REPLACED TO RESOLVE THE ISSUE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432941 ↗
• MalfunctionOct 30, 2025Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT THE SIDEPORT DETACHED FOR A LEAVE-IN SWAN PROCEDURE. IT WAS REPORTED THAT THE STAFF WERE ATTEMPTING TO INFUSE MEDICATIONS THROUGH THE SIDEPORT OF THE 7F SHEATH WITH A 7F SWAN IN PLACE. THE SHEATH AND THE SWAN WERE REPLACED TO RESOLVE THE ISSUE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432893 ↗
• MalfunctionOct 30, 2025Material Separation; Material Separation

  IT HAS BEEN REPORTED THAT THE SIDEPORT DETACHED FOR A LEAVE-IN SWAN PROCEDURE. IT WAS REPORTED THAT THE STAFF WERE ATTEMPTING TO INFUSE MEDICATIONS THROUGH THE SIDEPORT OF THE 7F SHEATH WITH A 7F SWAN IN PLACE. THE SHEATH AND THE SWAN WERE REPLACED TO RESOLVE THE ISSUE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23432731 ↗
• InjuryMar 21, 2025Material Separation; Material Separation

  THE PATIENT UNDERWENT A TAVR PROCEDURE ON (B)(6) 2025. WHILE STILL ADMITTED TO THE ICU ON (B)(6) 2025, IT WAS OBSERVED THAT THE PIGTAIL THAT CONNECTS TO THE IV TUBING BROKE OFF AT THE HUB. THE PATIENT EXPERIENCED SOME BLOOD LOSS, BUT NO TREATMENT WAS REQUIRED. THE CATHETER WAS EXCHANGED THROUGH THE EXISTING ACCESS SITE TO RESOLVE THE ISSUE. NO OTHER PATIENT EFFECTS BUT THE PATIENT IS STILL HOSPITALIZED. THE LINE WAS NOT PULLED OR MANIPULATED IN ANY WAY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21664005 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RIGHT HEART CATHETERIZATION PROCEDURE, BLEED BACK FROM THE FAST-CATH INTRODUCER WAS NOTED AFTER REMOVAL OF THE NON-ABBOTT (7F SWAN GANZ) CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444404 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RIGHT HEART CATHETERIZATION PROCEDURE, BLEED BACK FROM THE FAST-CATH INTRODUCER WAS NOTED AFTER REMOVAL OF THE NON-ABBOTT (7F SWAN GANZ) CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20443193 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RIGHT HEART CATHETERIZATION PROCEDURE, A BLEED BACK ISSUE WAS NOTED AFTER REMOVAL OF THE NON-ABBOTT (7F SWAN GANZ) CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20442721 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RIGHT HEART CATHETERIZATION PROCEDURE, BLEED BACK FROM THE FAST-CATH INTRODUCER WAS NOTED AFTER REMOVAL OF THE NON-ABBOTT (7F SWAN GANZ) CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SHEATH WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20436647 ↗
• MalfunctionOct 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RIGHT HEART CATHETERIZATION PROCEDURE, BLEED BACK FROM THE FAST-CATH INTRODUCER WAS NOTED AFTER REMOVAL OF THE NON-ABBOTT (7F SWAN GANZ) CATHETER. THE FAST-CATH INTRODUCER HAD TO BE REMOVED RESULTING IN LOSS OF VENOUS ACCESS. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. THE SHEATH WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20433993 ↗
• MalfunctionOct 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RIGHT HEART CATHETERIZATION PROCEDURE, A BLEED BACK ISSUE WAS NOTED AFTER REMOVAL OF THE NON-ABBOTT (7F SWAN GANZ) CATHETER. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE SHEATH WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427404 ↗
• MalfunctionFeb 20, 2023Material Separation; Use of Device Problem; Material Separation; Use of Device Problem

  AN EXPIRED FAST-CATH INTRODUCER WAS USED FOR TRANSVENOUS PACEMAKER PLACEMENT AND THE VENOUS ACCESS DETACHED FROM THE INTRODUCER WHILE THE DEVICE WAS IN THE PATIENT. ALL PARTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405997 ↗
• MalfunctionJul 29, 2020Material Separation; Material Separation

  DURING THE PREOPERATIVE PERIOD OF A PERMANENT PACEMAKER IMPLANTATION PROCEDURE, THE SIDEPORT OF THE DEVICE DETACHED, WHICH RESULTED IN AN INTERRUPTION OF VITAL MEDICATION INFUSION. THE PROCEDURE WAS COMPLETED BY REMOVING THE DEVICE AND IMPLANTING THE PERMANENT PACEMAKER. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10337971 ↗
• InjuryApr 17, 2020Difficult to Insert; Difficult to Insert

  DURING A PROCEDURE, IT WAS NOTED TO BE DIFFICULT TO INSERT THE INTRODUCER INTO THE PATIENT AND REQUIRED AN ADDITIONAL SUBCLAVIAN PUNCTURE TO COMPLETED THE PROCEDURE. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9971660 ↗
• MalfunctionFeb 7, 2020Material Separation; Material Separation

  A 5F PACING CATHETER AND AN INTRODUCER WERE PUT INTO THE PATIENT IN THE CATH LAB ON 03 (B)(6) 2020 AND THE PATIENT WAS SENT TO CVICU. ON A LATER DATE, WHEN THE PATIENT WAS BEARING DOWN FOR A BOWEL MOVEMENT AND COUGHED, THE SIDEPORT CAME OFF THE INTRODUCER. THE LINE WAS DISCONNECTED AND THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9683898 ↗