Fast-Cath™ 406948Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 05414734203531), received between Aug 14, 2018 and Feb 3, 2026 — classified as 5 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (15 reports).

2 other recalls cover devices cleared under the same FDA submission (K982187); they may or may not involve this specific model.

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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM, AND A NON-ABBOTT RING CATHETER WAS INSERTED. BLOOD LEAKAGE FROM THE HEMOSTATIC VALVE WAS OBSERVED AFTER FLUSHING. 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 24246286 ↗
• MalfunctionJun 19, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL TACHYCARDIA PROCEDURE, THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM. THE NON-ABBOTT DEVICE (BEEAT CATHETER BY JAPAN LIFELINE) WAS INSERTED INTO THE SHEATH AND WHEN NEGATIVE PRESSURE WAS APPLIED FOR FLUSHING, AIR WAS ASPIRATED. AIR WAS ASPIRATED SEVERAL TIMES, BUT IT COULD NOT BE COMPLETELY REMOVED. 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 22289486 ↗
• MalfunctionJun 17, 2025Gas/Air Leak; Gas/Air Leak

  DURING THE PULSED FIELD ABLATION PROCEDURE, AIR WAS ASPIRATED FROM THE SHEATH WHEN PERFORMING BROCKENBROUGH. 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 22236473 ↗
• MalfunctionJun 17, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE, WHEN THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM, THE RV CATHETER (MODEL: IBI-81521) WAS INSERTED INTO THE SHEATH, AFTER THE SEPTAL PUNCTURE WAS PERFORMED AND THE RING CATHETER (A NON-ABBOTT PRODUCT) WAS INSERTED, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE. THERE WAS NO MOVEMENT OF AIR INTO THE PATIENT¿S BODY. NO ADDITIONAL VENIPUNCTURE OR SEPTAL PUNCTURE WAS PERFORMED WHEN THE INTRODUCER WAS REPLACED. NO PARTICULAR RESISTANCE WAS OBSERVED WHEN A DILATOR WAS FIRST INSERTED INTO THE SHEATH HEMOSTASIS VALVE. THE DILATOR WAS INSERTED INTO THE SHEATH BEFORE INSERTION OF THE TRANSSEPTAL NEEDLE, AND IT WAS USED CORRECTLY AS PER THE PROCEDURE. THE ONLY DEVICES INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WERE THE INCLUDED DILATOR, THE RV CATHETER (MODEL: IBI-81521), AND THE RING CATHETER (A NON-ABBOTT PRODUCT). 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 22229540 ↗
• MalfunctionMay 16, 2025Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AIR LEAKED FROM THE SHEATH VALVE DURING ASPIRATION. THE SHEATH WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCE FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22037790 ↗
• MalfunctionJan 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT INCLUDES AN UPDATED EVENT DESCRIPTION. DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR EMBOLISM OCCURRED RESULTING IN CARDIAC ARREST WHICH REQUIRED INTUBATION AND CPR TO STABILIZE THE PATIENT. THE INTRODUCER WAS INSERTED INTO THE RIGHT ATRIUM USING THE GUIDEWIRE INCLUDED WITH THE INTRODUCER, THEN A SEPTAL PUNCTURE WAS PERFORMED, AND IT WAS POSITIONED INTO THE LEFT ATRIUM USING THE GUIDEWIRE INCLUDED WITH THE INTRODUCER. THE SHEATH WAS REPLACED WITH A NON-ABBOTT GUIDEWIRE AND SHEATH (MEDTRONIC) FOR CRYO. WHEN THE GUIDEWIRE WAS INSERTED INTO THE SHEATH, THE PATIENT'S BLOOD PRESSURE DROPPED. UP TO THIS POINT, THE DEVICES INSERTED INTO THE LEFT ATRIUM WERE THE REPORTED INTRODUCER AND THE GUIDEWIRE OF A SHEATH INTRODUCER FOR CRYO. FLUOROSCOPY CONFIRMED A LARGE AMOUNT OF AIR IN THE LEFT VENTRICLE. ATRIOVENTRICULAR BLOCK OCCURRED, FOLLOWED BY BRADYCARDIA AND CARDIAC ARREST. EMERGENCY TREATMENT WAS PERFORMED. THE PATIENT STABILIZED AND WAS PLACED UNDER OBSERVATION IN THE ICU. THE SHEATH WAS USED ACCORDING TO THE IFU. THE PHYSICIAN BELIEVES THAT THE AIR ENTRAINMENT MAY HAVE BEEN CAUSED BY PERFORMING THE DEVICE EXCHANGE WHILE THE LEFT ATRIAL PRESSURE WAS LOW. A TOTAL OF THREE DEV

  Patient problems: Air Embolism; Cardiac Arrest

  MAUDE report 21093701 ↗
• MalfunctionNov 26, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE SHEATH WAS INSERTED INTO THE CARDIAC CAVITY, AND BEFORE THE CATHETER WAS INSERTED, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE HOSPITAL DISCARDED THE REPORTED SHEATH. AIR CONTAMINATION TO THE PATIENT HAS NOT BEEN CONFIRMED. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED DUE TO SHEATH REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20785676 ↗
• MalfunctionAug 9, 2024Gas/Air Leak; Gas/Air Leak

  DURING A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE, WHEN THE SHEATH WAS INSERTED INTO THE HEART CHAMBER AND NEGATIVE PRESSURE WAS APPLIED FOR FLUSHING, AIR WAS ASPIRATED FROM THE SHEATH. ASPIRATING AIR WAS ATTEMPTED MULTIPLE TIMES WITH NO RESOLUTION. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. AIR CONTAMINATION INTO THE PATIENT HAS NOT BEEN CONFIRMED. THE ONLY PRODUCT INSERTED DIRECTLY INTO THE HEMOSTASIS VALVE WAS THE INCLUDED DILATOR. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19952632 ↗
• MalfunctionNov 3, 2023Gas/Air Leak; Gas/Air Leak

  DURING A CRYO-ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, WHEN INSERTING THE CATHETER INTO THE SHEATH, AIR ENTERED. NEGATIVE PRESSURE WAS APPLIED WITH THE SYRINGE, AND AIR ENTERED WHEN IT WAS PULLED STRONGLY, BUT NO AIR ENTERED WHEN IT WAS PULLED GENTLY. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE SHEATH AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. AFTER THE PROCEDURE, BEFORE HEMOSTASIS, A SIMILAR ISSUE WAS OBSERVED EVEN THOUGH THERE WAS NO CATHETER INSIDE THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18062970 ↗
• MalfunctionSep 8, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A SHEATH PUNCTURE OCCURRED WHILE INSERTING THE NEEDLE INTO THE HEMOSTATIC VALVE. AFTER STARTING PROCEDURE AND INTRODUCING THE SHEATH INTO THE PATIENT, RESISTANCE WAS NOTED WHEN INSERTING THE NEEDLE. THE NEEDLE AND SHEATH WERE THEN REMOVED FROM THE PATIENT AND THE SHEATH WAS NOTED TO BE PUNCTURED. ANOTHER NEEDLE AND INTRODUCER WERE USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17710397 ↗
• MalfunctionSep 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A BLOOD LEAK WAS NOTED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17699424 ↗
• MalfunctionAug 17, 2023Gas/Air Leak; Gas/Air Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THERE WAS AN AIR LEAK IN THE SHEATH. THE SHEATH WAS INSERTED INTO THE HEART AND BEFORE INSERTING THE CATHETER, FLUSHING WAS PERFORMED WITH PHYSIOLOGICAL SALINE. AIR WAS THEN ASPIRATED FROM THE FLUSH PORT. ASPIRATION WAS DONE A FEW TIMES BUT THE AIR COULD NOT BE COMPLETELY PULLED OUT. 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 17561801 ↗
• MalfunctionJul 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE AF PROCEDURE, WHEN THE SHEATH WAS INSERTED INTO THE HEART CHAMBER AND CATHETER (BIOSENSE PENTARAY ) WAS INSERTED, BLOOD LEAKED FROM THE HEMOSTASIS HUB. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL VENIPUNCTURE OR SEPTAL PUNCTURE WAS PERFORMED FOR SHEATH REPLACEMENT. ONLY DILATOR AND CATHETER (PENTARAY) WERE THE PRODUCTS THAT WERE INSERTED INTO THE SHEATH HEMOSTATIC VALVE. THE HOSPITAL DISCARDED THE REPORTED INTRODUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336092 ↗
• MalfunctionMay 8, 2023Fluid/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. NO ADDITIONAL PUNCTURE SITE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887484 ↗
• InjuryFeb 27, 2023Entrapment of Device; Entrapment of Device

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE INTRODUCER GOT STUCK IN THE FEMORAL VEIN AND BROKE APART. THE LOCK TORE AND THERE WAS NO RESISTANCE. THE HALF OF THE INTRODUCER THAT WAS OUT OF THE PATIENT WAS FRAYED ON THE END. THE OTHER HALF OF THE INTRODUCER WAS STILL IN THE PATIENT'S BODY, REQUIRING VASCULAR SURGERY FOR REMOVAL. A NON-ABBOTT MERIT MEDICAL SNARE WAS USED AND THE OTHER HALF OF THE INTRODUCER WAS SUCCESSFULLY EXTRACTED. THE INTRODUCER HAD SEVERAL DEFORMATIONS DUE TO THE USE OF THE ONE SNARE. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE AND IT WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16445877 ↗
• InjuryDec 4, 2022Gas/Air Leak; Gas/Air Leak

  DURING THAT ATRIAL FIBRILLATION CRYOABLATION PROCEDURE, THE PATIENT EXPERIENCED AN AIR EMBOLISM. THE EMBOLISM OCCURRED AFTER THE TRANSSEPTAL PUNCTURE, WHEN THE PHYSICIAN REMOVED THE NEEDLE AND THE DILATATOR AND RE-INSERTED THE GUIDEWIRE INTO THE SHEATH. IT IS THOUGHT THAT THE AIR ENTERED THE SHEATH WHEN THE VALVE-PASS WAS PLACED IN THE VALVE TO INSERT THE GUIDEWIRE. IT IS POSSIBLE THAT THE VALVE-PASS OBSTRUCTED THE IRRIGATION ENTRY OF THE SHEATH SO THE AIR WAS ALLOWED INTO THE LEFT ATRIUM. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS PLACED IN A HYPERBARIC CHAMBER. THE PATIENT IS STABLE.

  Patient problems: Air Embolism; Arrhythmia

  MAUDE report 15912886 ↗
• MalfunctionNov 15, 2022Fracture; Material Separation; Fracture; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A SHEATH DETACHMENT OCCURRED. THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM AND A NON ABBOTT DEVICE (JLL-REBERO 15MM CATHETER) WAS INSERTED INTO THE SHEATH. APPROXIMATELY 2 HOURS LATER, A SENSE OF INCONGRUITY WAS NOTED IN THE TRANSMISSION OF TORQUE WHILE OPERATING THE NON ABBOTT CATHETER AND THE SHEATH DETACHED FROM THE HUB. THE SHEATH WAS NOT REPLACED AS THE DETACHMENT OCCURRED WHEN CHECKING THE POTENTIAL OF THE ON ABBOTT CATHETER. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15796795 ↗
• MalfunctionSep 23, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED AFTER INSERTING THE SHEATH INTO THE PATIENT, WHEN ASPIRATING FROM THE SIDE PORT FOR FLUSHING. ASPIRATING THE AIR WAS ATTEMPTED SEVERAL TIMES BUT WAS NOT SUCCESSFUL. 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 15470516 ↗
• MalfunctionAug 30, 2022Material Puncture/Hole; Material Puncture/Hole

  DURING A TRANSSEPTAL APPROACH, THE NEEDLE PUNCTURED THE INTRODUCER. THE INTRODUCER WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319396 ↗
• MalfunctionMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE OF THE SHEATH. 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 14312268 ↗
• MalfunctionApr 19, 2022Gas/Air Leak; Gas/Air Leak

  DURING THE PROCEDURE, AIR BUBBLES WERE NOTED WHILE PERFORMING ASPIRATION AND IRRIGATION PROCESS. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142949 ↗
• MalfunctionFeb 10, 2022Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  DURING THE PROCEDURE, THE TRANSSEPTAL NEEDLE PUNCTURED THROUGH THE INTRODUCER WHILE INSERTED INTO THE PATIENT. INITIALLY IT WAS NOTED THAT DIFFICULTY WAS ENCOUNTERED WHILE INSERTING THE NEEDLE THROUGH THE INTRODUCER. A STYLET WAS NOT USED WITH THE NEEDLE. A NEW NEEDLE WAS USED, BUT THE SAME ISSUE OCCURRED. THE INTRODUCER WAS THEN REMOVED FROM THE PATIENT AND A PUNCTURE WAS NOTED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS ABLE TO BE CONTINUED AND COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13506189 ↗
• MalfunctionFeb 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE SHEATH WAS INTRODUCED, BLOOD WAS LEAKING 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 13417508 ↗
• MalfunctionOct 29, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE SHIELD OF THE HEMOSTASIS VALVE WAS LOOSE, AND A BLOOD LEAK OCCURRED. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12719682 ↗
• MalfunctionJun 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THERE WAS A LEAK FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. THE SHEATH WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999615 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K982187. One submission often covers many models, so check the product and lot details in each record.

• Z-1426-04 · Aug 4, 2004 · Terminated
  Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Left Lateral Reorder #407901. The product is package
• Z-1425-04 · Aug 4, 2004 · Terminated
  Telesheath Left Atrial Introducer System Right Superior. Telesheath Catheter Two-Piece Introducer Kit with Hemostasis Valve. Right Superior Reorder #407900. The product is packa