Fast-Cath™ 406704Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05414734216975), received between Feb 22, 2019 and Feb 24, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Fluid/Blood Leak

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, BLOOD LEAKED FROM THE HEMOSTATIC VALVE. WHEN THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM AND THE DILATOR WAS REMOVED, BLOOD LEAKAGE WAS OBSERVED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430450 ↗
• InjuryAug 26, 2025Gas/Air Leak; Gas/Air Leak

  DURING ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. WHEN A NON-ABBOTT CATHETER WAS INSERTED INTO THE SHEATH AND ASPIRATION WAS PERFORMED THROUGH THE SIDE PORT FOR FLUSHING, AIR WAS ASPIRATED. DESPITE MULTIPLE ATTEMPTS, THE AIR COULD NOT BE COMPLETELY REMOVED. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO AIR MOVEMENT INTO THE PATIENT WAS CONFIRMED. THE ONLY PRODUCTS INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WERE THE INCLUDED DILATOR AND THE NON ABBOTT CATHETER. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT. THERE WAS NO RESISTANCE WHEN INSERTING THE DILATOR. THE SHEATH AND DILATOR WERE INTEGRATED AND INSERTED AS PER THE PROCEDURE. THE HOSPITAL DISCARDED THE REPORTED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899029 ↗
• MalfunctionJun 6, 2023Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER THE SHEATH WAS INSERTED INTO THE BODY, THE SIDE PORT CAME OFF AND FELL TO THE FLOOR. THE SHEATH WAS PLUGGED FOR THE TIME BEING WHERE THE SIDE PORT CAME OFF, BUT IT IS NOT KNOWN WHAT WAS USED TO PLUG IT. THE SIDE PORT THAT FELL TO THE FLOOR WAS NOT REUSED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE INTRODUCER AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072201 ↗
• MalfunctionJan 18, 2023Material Separation; Material Separation

  FOLLOWING AN ATRIAL FIBRILLATION (AF) PROCEDURE, A PORTION OF THE SHEATH DETACHED AND REMAINED IN THE PATIENT. A SNARE (OSYPKA) WAS USED TO RETRIEVE THE DETACHED PORTION FROM THE PATIENT; ADDITIONAL FLUOROSCOPY TIME WAS NEEDED. THE PATIENT LEFT THE LAB IN A STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 16194291 ↗
• MalfunctionAug 10, 2022Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURING REF: 3005334138-2022-00467. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE, AIR WAS ASPIRATED INTO A SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATH. ALTHOUGH SEVERAL ASPIRATIONS WERE ATTEMPTED, AIR WAS STILL NOTED. THE SHEATH SET WAS REPLACED HOWEVER, AND AIR WAS AGAIN ASPIRATED. A THIRD SHEATH USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201185 ↗
• MalfunctionAug 10, 2022Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURING REF: 3005334138-2022-00468. DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE, AIR WAS ASPIRATED INTO A SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATH. ALTHOUGH SEVERAL ASPIRATIONS WERE ATTEMPTED, AIR WAS STILL NOTED. THE SHEATH SET WAS REPLACED HOWEVER, AND AIR WAS AGAIN ASPIRATED. A THIRD SHEATH USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201108 ↗
• MalfunctionAug 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) ABLATION PROCEDURE, A LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE SHEATH SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200957 ↗
• MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007291 ↗
• MalfunctionJun 8, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, AIR WAS ASPIRATED INTO A SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATH. SEVERAL ASPIRATIONS WERE ATTEMPTED BUT THE AIR REMAINED. THE SHEATH SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14636806 ↗
• MalfunctionMay 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING ATRIAL FIBRILLATION PROCEDURE, BLOOD WAS LEAKING FROM THE HEMOSTASIS VALVE OF THE SHEATH. THE SHEATH SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14347191 ↗
• MalfunctionApr 21, 2021Gas/Air Leak; Gas/Air Leak

  DURING CRYOABLATION FOR ATRIAL FIBRILLATION, AFTER PLACING THE SHEATH INTO THE PATIENT AND PLACING A 6F CATHETER INTO THE SHEATH, AIR WAS ASPIRATED INTO THE SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE SHEATH. SEVERAL ASPIRATIONS WERE ATTEMPTED BUT THE ISSUE REMAINED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11699840 ↗
• MalfunctionOct 22, 2020Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AN AIR LEAK WAS OBSERVED IN THE INTRODUCER. AIR WAS ASPIRATED INTO A SYRINGE CONNECTED TO THE INTRODUCER SIDEPORT AFTER PLACING THE INTRODUCER INTO THE PATIENT AND PRIOR TO CATHETER INSERTION. SEVERAL ASPIRATION ATTEMPTS WERE MADE WITHOUT RESOLUTION OF THE ISSUE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717832 ↗
• MalfunctionOct 9, 2020Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AIR WAS ASPIRATED INTO THE SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF THE INTRODUCER. THE CATHETER WAS ALREADY INSERTED INTO THE PATIENT, AND DESPITE SEVERAL ASPIRATIONS, THE AIR WAS NOT ABLE TO BE REMOVED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10656008 ↗
• InjuryFeb 22, 2019Material Separation; Material Separation

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A PORTION OF THE SHEATH BECAME DETACHED INSIDE THE PATIENT. THE 6.5F SHEATH WAS INTRODUCED INTO THE VEIN BUT THERE WAS SOME INSERTION DIFFICULTY WITH ATTEMPTING TO INSERT THE 4F CATHETER INTO THE SHEATH. AFTER THE PROCEDURE WAS COMPLETED A SMALL HEMATOMA WAS NOTED AND WHEN THE SHEATH WAS REMOVED THE VALVE BECAME DETACHED AND THE SHEATH REMAINED IN THE VEIN. INTERVENTION WAS PERFORMED TO REMOVE THE REMAINDER OF THE SHEATH, WHICH WAS CONFIRMED ON FLUOROSCOPY AND ECHOCARDIOGRAM.

  Patient problems: Device Embedded In Tissue or Plaque; Hematoma

  MAUDE report 8362776 ↗