Fast-Cath™ 406844Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05414734202930), received between Jul 10, 2018 and Jul 21, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2025Fracture; Fracture

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN ATTEMPTING TO INSERT THE SHEATH INTO THE VEIN, IT WAS FOUND THAT THE BASE OF THE SHEATH HUB WAS FRACTURED. 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 22555475 ↗
• MalfunctionJun 4, 2025Material Separation; Material Separation

  DURING A LEFT-SIDED PVI/ATRIAL FIBRILLATION PROCEDURE, THE SIDEPORT WAS DISCONNECTED FROM THE DEVICE. 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 22143794 ↗
• MalfunctionFeb 23, 2024Material Puncture/Hole; Material Puncture/Hole

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE SHEATH WAS DAMAGED DURING USE. THERE WERE SMALL HOLES IN THE SHEATH. THE SHEATH WAS REPLACED, AND THE PROCEDURE CONTINUED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767933 ↗
• MalfunctionFeb 1, 2024Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  DURING THE ABLATION PORTION OF AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE, INSERTION DIFFICULTIES WITH THE SHEATH RESULTED IN A PROCEDURAL DELAY. IT WAS NOTED THAT THE ABLATION CATHETER WAS NOT REACHING THE SET POWER LIMIT ON THE AMPERE. THE CATHETER WAS REMOVED FROM THE PATIENT, AND IT WAS OBSERVED THAT THE CATHETER WAS NOT IRRIGATING DESPITE ATTEMPTING TO FAST FLUSH AT 60 ML/MIN. THE INTRODUCER AND THE ABLATION CATHETER WERE EXCHANGED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. WHEN THE GUIDEWIRE WAS REMOVED DURING THE DEVICE EXCHANGE IT WAS NOTED TO BE BENT AND KINKED. AFTER DISCUSSING WITH THE TEAM WHAT WE SAW, IT SEEMS THAT THE SHEATH DAMAGED BOTH THE WIRE AND THE ABLATION CATHETER WHEN THEY WERE ADVANCED INTO THE PATIENT THROUGH THIS SHEATH. NO RESISTANCE WAS NOTED WHILE INSERTING THE CATHETER THROUGH THE SHEATH BUT THERE WAS RESISTANCE WHEN REMOVING IT FROM THE PATIENT. WHEN THE INTRODUCER WAS EXCHANGED, THE NEW INTRODUCER WAS ADVANCED THROUGH THE EXISTING ACCESS SITE. WHEN THE SHEATH WAS REMOVED, NO PHYSICAL DAMAGE WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18624071 ↗
• MalfunctionSep 13, 2023Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURING REFERENCE: 3005334138-2023-00398. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AN AIR LEAK OCCURRED. THE DEVICE WAS EXCHANGED AND AN AIR LEAK OCCURRED AGAIN. THE SECOND DEVICE WAS REPLACED WHICH RESOLVED THE ISSUE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE TRANSEPTAL PUNCTURE WAS PERFORMED AND THE PHYSICIAN SUCCESSFULLY POSITIONED TO THE LEFT SIDE. WHEN A SYRINGE WAS USED TO ASPIRATE BLOOD, AIR ENTERED THE SYRINGE. THE SHEATH WAS EXCHANGED AND AGAIN HE GOT AIR. THE SECOND SHEATH WAS EXCHANGED FOR A THIRD WHICH APPEARED TO BE WORKING AS EXPECTED. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AND DO AN ULTRASOUND CHECK FOLLOWED BY SENDING THE PATIENT FOR AN RX SCAN. THE RESULT OF THE SCAN IS TOTALLY NORMAL AND THE PATIENT HAS NO CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737395 ↗
• MalfunctionSep 13, 2023Gas/Air Leak; Gas/Air Leak

  RELATED MANUFACTURING REFERENCE: 3005334138-2023-00399. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AN AIR LEAK OCCURRED. THE DEVICE WAS EXCHANGED AND AN AIR LEAK OCCURRED AGAIN. THE SECOND DEVICE WAS REPLACED WHICH RESOLVED THE ISSUE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE TRANSEPTAL PUNCTURE WAS PERFORMED AND THE PHYSICIAN SUCCESSFULLY POSITIONED TO THE LEFT SIDE. WHEN A SYRINGE WAS USED TO ASPIRATE BLOOD, AIR ENTERED THE SYRINGE. THE SHEATH WAS EXCHANGED AND AGAIN HE GOT AIR. THE SECOND SHEATH WAS EXCHANGED FOR A THIRD WHICH APPEARED TO BE WORKING AS EXPECTED. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AND DO AN ULTRASOUND CHECK FOLLOWED BY SENDING THE PATIENT FOR AN RX SCAN. THE RESULT OF THE SCAN IS TOTALLY NORMAL AND THE PATIENT HAS NO CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737379 ↗
• MalfunctionDec 7, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED. A NON-ABBOTT RF NEEDLE (BAYLIS RF NEEDLE) WAS INSERTED INTO THE SHEATH AND DILATOR FOR SEPTAL PUNCTURE, AND A NON-ABBOTT DEVICE (BIOSENSE PENTARAY) WAS INSERTED INTO THE SHEATH, CAUSING BLOOD TO LEAK FROM THE HEMOSTASIS VALVE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES. NO ADDITIONAL SEPTAL PUNCTURE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932260 ↗
• MalfunctionNov 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FLUTTER ABLATION PROCEDURE, WHEN THE SHEATH WAS INSERTED INTO THE HEART, BLOOD LEAKAGE 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 15853278 ↗
• MalfunctionJul 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THERE WAS A BLOOD LEAK FROM THE HEMOSTASIS VALVE. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15018574 ↗
• MalfunctionOct 20, 2021Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AN AIR LEAK OCCURRED. WHILE WATER WAS DRAWN FROM THE SIDE PORT, AIR WAS ASPIRATED. 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 12664753 ↗
• MalfunctionAug 17, 2021Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CRACK WAS NOTED ON THE TIP OF THE DILATOR AND A BLOOD LEAK OCCURRED. THE SHEATH WAS REPLACED WITH THE SAME MODEL DEVICE TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12330390 ↗
• MalfunctionJul 12, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING A CRYO-PULMONARY VEIN ISOLATION PROCEDURE, DURING TRANSSEPTAL PUNCTURE, IT WAS NOTICED THAT THE SHEATH BECAME PUNCTURED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149100 ↗
• MalfunctionApr 21, 2021Fracture; Fracture

  DURING THE PROCEDURE, RESISTANCE WAS NOTED WHEN TRYING TO REMOVE SHEATH AT END OF CASE AND ONCE REMOVED, A TEAR WAS NOTED IN THE SHAFT OF THE SHEATH. THE CASE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11701942 ↗
• MalfunctionFeb 25, 2021Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AN AIR LEAK OCCURRED. AFTER PUNCTURING INTO THE RIGHT FEMORAL VEIN, AIR WAS ASPIRATED INTO THE DEVICE WHEN FLUSHED. 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 11378987 ↗
• MalfunctionDec 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN AF ABLATION PROCEDURE, A BLOOD LEAK OCCURRED. WHEN INSERTING THE SHEATH, A CRACK WAS NOTED ON THE TIP OF THE INNER SHEATH ALLOWING BLOOD TO LEAK FROM THE CRACK. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

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

  MAUDE report 11021649 ↗
• MalfunctionDec 8, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN AF ABLATION PROCEDURE, A BLOOD LEAK OCCURRED. AFTER INSERTING THE BRK NEEDLE INTO THE HEMOSTASIS VALVE A BLOOD LEAK OCCURRED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10967875 ↗
• MalfunctionDec 3, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING A RIGHT-SIDED ABLATION PROCEDURE, A BLOOD LEAK WAS OBSERVED FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10939794 ↗
• MalfunctionNov 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A BLOOD LEAK WAS NOTED. THE SHEATH WAS REPLACED WITH THE SAME MODEL DEVICE TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT. IN ABSENCE OF PATIENT'S WRITTEN CONSENT AS REQUIRED BY THE PERSONAL DATA PROTECTION NATIONAL LEGISLATION. NATIONAL LEGISLATION PREVENTS THE RECORDING OF SUCH INFORMATION. A WRITTEN CONSENT HAS NOT BEEN OBTAINED IN THIS CASE; THEREFORE, THIS INFORMATION IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10795426 ↗
• MalfunctionMay 11, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE INTRODUCER WAS USED TO INSERT THE CURVED GUIDING SHEATH TUBE; HOWEVER, THE HEMOSTASIS VALVE WAS FOUND TO BE LEAKING BLOOD. THE SHEATH WAS REPLACED AND THE OPERATION WAS SUCCESSFULLY COMPLETED WITHOUT ANY ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10042501 ↗
• MalfunctionSep 3, 2019Leak/Splash; Leak/Splash

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A HEMOSTASIS VALVE LEAK OCCURRED. A NEW SHEATH WAS USED TO COMPLETED THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8958601 ↗
• MalfunctionAug 29, 2019Leak/Splash; Leak/Splash

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A HEMOSTASIS VALVE LEAK OCCURRED. THE SHEATH WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944972 ↗
• MalfunctionJun 20, 2019Difficult to Insert; Difficult to Insert

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FOREIGN MATERIAL WITHIN THE SR0 GUIDING INTRODUCER DILATOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8717910 ↗
• MalfunctionFeb 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A BLOOD LEAK OCCURRED. WHEN THE LEAK WAS NOTED THE SHEATH WAS REMOVED AND NO ABNORMALITIES WERE NOTED. A NEW SHEATH WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8306403 ↗
• MalfunctionJan 22, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, THE FAST-CATH INTRODUCER HAD BLOOD LEAK FROM THE VALVE. ANOTHER INTRODUCER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8269384 ↗
• MalfunctionDec 12, 2018Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, BLOOD WAS LEAKING FROM THE INTRODUCER. 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 8154712 ↗