Fast-Cath™ 406963Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05414734204057), received between Oct 12, 2018 and Dec 29, 2025 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Material Separation; Material Separation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE NON-ABBOTT CATHETER (JLL ELECTRODE CATHETER) WAS INSERTED, RESISTANCE WAS MET AND IT COULD NOT BE INSERTED. UPON INSPECTING THE SHEATH, IT WAS NOTED THAT THE CONNECTOR PARTS HAD BROKEN OFF. THERE WAS NO DAMAGE NOTED ON THE NON-ABBOTT CATHETER (JLL ELECTRODE CATHETER). 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 23918752 ↗
• MalfunctionSep 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS 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 20310835 ↗
• MalfunctionJun 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, IT WAS NOTED THAT THE VALVE OF THE SHEATH WAS LEAKING. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED DEVICE DUE TO THE PATIENT BEING INFECTED. ONLY THE DILATOR WAS INSERTED IN THE SHEATH. THERE WAS NO CONFIRMED AIR ASPIRATION OR AIR CONTAMINATION TO THE PATIENT'S BODY. NO ADDITIONAL PUNCTURE WAS PERFORMED WHEN THE SHEATH WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19507012 ↗
• MalfunctionApr 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PULMONARY SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE HEMOSTASIS VALVE DID NOT CLOSE PROPERLY, ALLOWING BLOOD TO LEAK. THE INTRODUCER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19177894 ↗
• MalfunctionApr 9, 2024Material Separation; Material Separation

  DURING DEVICE PREPARATION, WHEN THE PACKAGE WAS OPENED, IT WAS NOTED THAT THE THREE-WAY STOPCOCK WAS NOT ATTACHED. 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 19076036 ↗
• MalfunctionAug 30, 2023Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED. 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 17655095 ↗
• MalfunctionAug 1, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, AIR WAS ASPIRATED FROM PART OF THE TUBE LOCK. 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 15142119 ↗
• MalfunctionJul 12, 2022Gas/Air Leak; Gas/Air Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, AIR WAS ASPIRATED FROM THE THREE PORTS WHEN THE SHEATH WAS PLACED IN THE LEFT THIGH AND NEGATIVE PRESSURE WAS APPLIED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PHYSICIAN CONFIRMED THAT AIR WAS NOT MOVED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14989125 ↗
• MalfunctionSep 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PVST) ABLATION PROCEDURE, A BLOOD LEAK OCCURRED. AFTER PLACING THE SHEATH, BLOOD BEGAN TO LEAK FROM ONE OF THE HEMOSTASIS VALVES OF THE SHEATH. THE SHEATH SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL FEMORAL VEIN PUNCTURE WAS REQUIRED FOR REPLACING THE SHEATH. THE DEVICE WILL NOT RETURN AS THE PATIENT WAS HCV POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507560 ↗
• MalfunctionJun 6, 2021Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AND AIR LEAK OCCURRED. AFTER PLACING THE SHEATH, AND PRIOR TO INSERTING CATHETERS INTO THE SHEATH, AIR WAS ASPIRATED INTO A SYRINGE THAT CONNECTED TO THE EXTENSION PORT OF ONE OF THE PORTS. SEVERAL ASPIRATIONS WERE ATTEMPTED BUT THE AIR WAS STILL ASPIRATED. 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 11944650 ↗
• MalfunctionFeb 10, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A BLOOD LEAK OCCURRED. WHEN THE SHEATH WAS INSERTED, BLOOD BEGAN TO LEAK FROM THE HEMOSTASIS VALVE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11308880 ↗
• MalfunctionJan 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE IRRIGATION TUBING DETACHED FROM THE SHEATH HUB, NOT THE SIDEPORT AS PREVIOUSLY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9632842 ↗
• MalfunctionJan 6, 2020Material Separation; Material Separation

  FOLLOWING THE PROCEDURE, WHEN THE INTRODUCER WAS REMOVED FROM THE PATIENT, THE SHAFT OF THE SHEATH DETACHED FROM THE INTRODUCER. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552682 ↗
• MalfunctionDec 27, 2019Material Separation; Material Separation

  FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, WHILE REMOVING THE SHEATH FROM THE PATIENT, THE TRIO HUB WAS KINKED AND DETACHED FROM THE SHEATH. THERE WAS NO RESISTANCE NOTED TO REMOVE THE SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE SHEATH. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9526923 ↗
• MalfunctionAug 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ATRIAL FIBRILLATION PROCEDURE, ONE OF THE HEMOSTASIS VALVES DETACHED FROM THE SHEATH. A NON-ABBOTT INTRODUCER WAS INSERTED THROUGH THE VALVE AT THE TIME. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8865320 ↗
• MalfunctionFeb 21, 2019Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, THE INTRODUCER WAS INSERTED INTO THE PATIENT AND AIR ENTERED WHEN ASPIRATING BLOOD FROM THE GREEN PORT OF THE HEMOSTASIS VALVE WITH THE SYRINGE. NO ABNORMALITIES WERE NOTED UPON SHEATH REMOVAL. 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 8360637 ↗
• MalfunctionOct 12, 2018Gas/Air Leak; Gas/Air Leak

  FOLLOWING INSERTION OF THE INTRODUCER, AIR ENTERED THE HEMOSTASIS VALVE WHILE ASPIRATING BLOOD. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962092 ↗