Fast-Cath™ 406853Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 05414734202985), received between Jul 18, 2018 and Jul 30, 2025 — classified as 5 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (11 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Material Puncture/Hole; Material Puncture/Hole

  DURING THE SVT PROCEDURE, IT WAS NOTED THAT THE SHEATH WAS PUNCTURED AFTER BEING IN THE PATIENT. THE SHEATH WAS REPLACED, AND THE PROCEDURE CONTINUED WITHOUT ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664391 ↗
• InjurySep 16, 2024Material Puncture/Hole; Device Contamination with Body Fluid; Material Puncture/Hole; Device Contamination with Body Fluid

  RELATED MANUFACTURING REF: 3005334138-2024-00353, 3008452825-2024-00488. DURING AN ATRIAL FIBRILLATION PROCEDURE, THE TRANSSEPTAL NEEDLE WITH STYLET WENT THROUGH THE INTRODUCER DURING TRANSSEPTAL PUNCTURE. THE INTRODUCER WAS EXCHANGED, HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS THEN CANCELLED DUE TO A THROMBUS NOTED IN THE LEFT ATRIUM. THE THROMBUS WAS NOT PRESENT PRIOR TO THE PROCEDURE. THE PHYSICIANS CONSIDERED IT A MEDICAL CONDITION OF THE PATIENT. THE PATIENT'S NEUROLOGICAL STATUS WAS CHECKED, AND EVERYTHING WAS STABLE AT THE END OF THE PROCEDURE. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT 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: Thrombosis/Thrombus

  MAUDE report 20230115 ↗
• InjurySep 16, 2024Material Puncture/Hole; Device Contamination with Body Fluid; Material Puncture/Hole; Device Contamination with Body Fluid

  RELATED MANUFACTURING REF: 3005334138-2024-00352, 3008452825-2024-00488 DURING AN ATRIAL FIBRILLATION PROCEDURE, THE TRANSSEPTAL NEEDLE WITH STYLET WENT THROUGH THE INTRODUCER DURING TRANSSEPTAL PUNCTURE. THE INTRODUCER WAS EXCHANGED, HOWEVER THE SAME ISSUE OCCURRED. THE PROCEDURE WAS THEN CANCELLED DUE TO A THROMBUS NOTED IN THE LEFT ATRIUM. THE THROMBUS WAS NOT PRESENT PRIOR TO THE PROCEDURE. THE PHYSICIANS CONSIDERED IT A MEDICAL CONDITION OF THE PATIENT. THE PATIENT'S NEUROLOGICAL STATUS WAS CHECKED, AND EVERYTHING WAS STABLE AT THE END OF THE PROCEDURE. PATIENT'S INFORMATION (E.G. AGE, WEIGHT, GENDER, ETHNICITY, RACE, PATIENT'S INITIALS) CANNOT BE HANDLED BY ABBOTT 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: Thrombosis/Thrombus

  MAUDE report 20226966 ↗
• MalfunctionMar 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH AFTER INSERTION. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969672 ↗
• MalfunctionSep 30, 2023Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE DILATOR THAT CAME WITH THE SHEATH WAS STRAIGHT. WHEN THE NEEDLE WAS ADVANCED THROUGH THE DILATOR, IT WAS NOTED THAT IT POKED THROUGH THE SIDE OF THE DILATOR AND DISTAL PART OF THE SHEATH. THE SHEATH AND DILATOR WERE EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17849321 ↗
• MalfunctionSep 13, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE PROCEDURE, WHEN ADVANCING THE GUIDEWIRE THROUGH THE INTRODUCER INTO THE PATIENT, THE GUIDEWIRE PUNCTURED THE INTRODUCER. THE GUIDEWIRE AND THE INTRODUCER WERE REMOVED AND EXCHANGED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17740300 ↗
• MalfunctionJun 6, 2023Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS TO ADVISE OF A PERFORATION FOUND IN THE SHEATH DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17076401 ↗
• MalfunctionMay 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PREMATURE VENTRICULAR CONTRACTION'S PROCEDURE, THE SHEATH HEMOSTASIS VALVE IS DAMAGED, AND A BLOOD LEAK WAS NOTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988108 ↗
• MalfunctionFeb 28, 2023Difficult to Insert; Difficult to Insert

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS WHICH REVEALED A PUNCTURED DILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454609 ↗
• InjuryDec 12, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THERE WAS AN AIR LEAK FROM THE SEAL OF THE INTRODUCER RESULTING IN ST ELEVATION, AV BLOCK, AND HYPOTENSION. AIR WAS BEING ASPIRATED INTO THE LEFT ATRIUM. THE NON-ABBOTT CATHETER WAS INSERTED INTO THE INTRODUCER, THERE WAS A RESISTANCE THAT COULD BE OVERCOME WITH A LITTLE PRESSURE. DURING THE SUBSEQUENT ASPIRATION OF THE INTRODUCER, THERE WAS ALREADY AIR IN THE SYSTEM. THE AIRLOCK HAD ALREADY BEEN RINSED AND CONNECTED TO THE CONTINUOUS RINSING SYSTEM, WHICH WAS EMPTY OF AIR. THE PATIENT WAS STABILIZED WITH 100% OXYGEN, RV PACING, HEAD DOWN POSITION, AND CORONARY ANGIOGRAPHY WITH NO LONG-TERM CONSEQUENCES OR DAMAGE.

  Patient problems: Arrhythmia; Heart Block

  MAUDE report 15965053 ↗
• MalfunctionNov 15, 2022Material Puncture/Hole; Material Puncture/Hole

  THIS REPORT IS TO ADVISE OF A PERFORATION FOUND IN THE INTRODUCER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15801870 ↗
• MalfunctionOct 25, 2021Material Puncture/Hole; Improper or Incorrect Procedure or Method; Material Puncture/Hole; Improper or Incorrect Procedure or Method

  DURING A MTIRACLIP PROCEDURE, THE NEEDLE WITH STYLET PUNCTURED THRU THE TIP OF THE SRO DILATOR DURING TRANSSEPTAL APPROACH. THE DEVICE WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12689270 ↗
• MalfunctionSep 7, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN TRAIL FIBRILLATION (AF) PROCEDURE, A FLUID LEAK OCCURRED. AFTER INTRODUCING THE SHEATH, THERE WAS A LEAK COMING FROM THE PROXIMAL VALVE COMPONENT. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12435240 ↗
• MalfunctionJul 21, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, A LEAK WAS NOTED IN THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202346 ↗
• MalfunctionJun 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT PROCEDURE WITH CRYO, A BLOOD LEAK WAS NOTED AT THE HEMOSTASIS VALVE WHEN CHANGING THE SHEATH FROM CRYO TO RF. ANOTHER INTRODUCER FROM THE SAME MODEL WAS USED TO CONTINUE THE CASE SUCCESSFULLY WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12083763 ↗
• MalfunctionJun 24, 2021Material Twisted/Bent; Material Twisted/Bent

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A PUNCTURED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12061061 ↗
• MalfunctionJun 21, 2021Difficult to Insert; Improper or Incorrect Procedure or Method; Difficult to Insert; Improper or Incorrect Procedure or Method

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A PUNCTURED SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12032172 ↗
• MalfunctionJan 8, 2021Fracture; Stretched; Fracture; Stretched

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, THE DEVICE WAS PLACED INTO THE PATIENT AND AFTER REMOVING THE DILATOR, THE SOFT TIP OF THE SHEATH WAS NOTED TO BE FLARED. ADDITIONALLY, THE SHAFT OF THE INTRODUCER FRACTURED JUST ABOVE THE HUB. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 11143042 ↗
• MalfunctionJun 9, 2020Material Separation; Material Separation

  DURING THE PROCEDURE, THE SIDEPORT TUBING HAD DETACHED FROM THE INTRODUCER. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132651 ↗
• InjuryMar 16, 2020Entrapment of Device; Entrapment of Device

  RELATED MANUFACTURING REFERENCE: 3005334138-2020-00106. FOLLOWING AN ATYPICAL RIGHT ATRIAL FLUTTER PROCEDURE, AN ENTANGLEMENT REQUIRING SNARE REMOVAL OCCURRED. WHEN THE SHEATHS AND CATHETERS WERE BEING REMOVED FROM THE PATIENT, WITHDRAWAL DIFFICULTY WAS NOTED WITH THE ADVISOR CATHETER. FLOUROSCOPY CONFIRMED THE CATHETER WAS CAUSED IN THE DISTAL END OF THE SHEATH. MANIPULATION OF THE CATHETER WAS ATTEMPTED TO RELEASE THE CATHETER AND SHEARED THE INTRODUCER THAT WAS ADJACENT TO THE DEVICE IN TWO PIECES. THE PROXIMAL PORTION OF THE SHEATH WAS REMOVED, BUT A SNARING TOOL WAS UTILIZED TO REMOVE THE DISTAL PORTION OF THE SHEATH, WHICH APPEARED TO BE FULLY REMOVED FROM THE VEIN. IT WAS INDICATED BY THE PHYSICIAN THAT THE ADVISOR HAD WRAPPED AROUND THE SHEATH AND BECAME ENTANGLED. THE PATIENT WAS STABLE AND THE PROCEDURE WAS ABLE TO BE COMPLETED. THERE WAS NO DAMAGED NOTED TO THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835199 ↗
• MalfunctionDec 16, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE, BLOOD WAS LEAKING FROM THE VALVE OF THE SHEATH. 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 9473924 ↗
• MalfunctionOct 28, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE PROCEDURE A SHEATH BLOOD LEAK OCCURRED. A NEW SHEATH WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9248145 ↗
• InjuryOct 25, 2019Material Separation; Material Separation

  DURING AN ELECTROPHYSIOLOGY (EP) PROCEDURE A DEVICE DETACHMENT OCCURRED. AN SR0 SHEATH WAS USED FOR AN EP PROCEDURE ON (B)(6) 2019 USING TRANSSEPTAL APPROACH. AT THE END OF THE PROCEDURE THE SHEATH WAS REMOVED WHILST PLACING A Z-SUTURE AND THE SHEATH WAS INADVERTENTLY SHEARED LEAVING APPROXIMATELY 24 CM IN THE INFERIOR VENA CAVA (IVC). ON (B)(6) 2019 DURING AN ABLATION PROCEDURE THE DEVICE FRAGMENT WAS REMOVED FROM THE UPPER IVC USING A SNARE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Foreign Body In Patient

  MAUDE report 9240540 ↗
• MalfunctionJul 25, 2019Gas/Air Leak; Gas/Air Leak

  AFTER TRANSEPTAL ACCESS, BLOOD ASPIRATED FROM THE SIDE ARM WHEN AIR WAS PULLED BACK. UPON SEALING THE VALVE END OF THE SHEATH, BLOOD WAS ABLE TO RETURN. A NON-ABBOTT DEVICE WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828118 ↗
• MalfunctionMay 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A BLOOD LEAK OCCURRED. A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE DURING ABLATION WITH A LIVEWIRE CATHETER. A NEW SHEATH SET WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8587064 ↗