Inquiry™ IBI-81107Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05414734303002), received between Feb 5, 2019 and Sep 4, 2025 — classified as 14 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Activation, Positioning or Separation Problem; Material Split, Cut or Torn; Activation, Positioning or Separation Problem; Material Split, Cut or Torn

  THE REPORT IS TO ADVISE OF A CUT NOTED IN THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963592 ↗
• MalfunctionMar 25, 2024Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  DURING AN ATRIAL FLUTTER PROCEDURE, THE CATHETER WAS FRACTURED. IT WAS NOTED THAT THE CATHETER FORMED AN S SHAPE WHEN BENT. THE CATHETER WAS DIFFICULT TO REMOVE FROM THE PATIENT AND WAS DAMAGED IN THE PROCESS EXPOSING INTERNAL COMPONENTS. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE CONTINUED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18974381 ↗
• MalfunctionNov 27, 2023Fracture; Difficult to Insert; Fracture; Difficult to Insert

  DURING AN ATRIAL FIBRILLATION PROCEDURE, DIFFICULTIES WERE NOTED WHEN INSERTING THE CATHETER INTO THE PATIENT AND UPON REMOVAL, IT WAS NOTED TO BE FRACTURED. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209001 ↗
• MalfunctionMay 10, 2023Material Separation; Material Separation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE MAPPING CATHETER FRACTURED AT THE TIP AND WAS NOT ABLE TO BE REMOVED FROM THE PATIENT. THE CATHETER HANDLE WAS CUT OFF AND A SHEATH WAS USED TO REMOVE THE REST OF THE CATHETER FROM THE PATIENT. ALL PIECES WERE ACCOUNTED FOR USING FLUORO OR ECHO. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT CATHETER WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16902041 ↗
• InjuryApr 19, 2021Material Separation; Material Separation

  THE FOREIGN MATERIAL WAS RETURNED AND DETERMINED TO BE BIOLOGICAL TISSUE.

  Patient problems: Foreign Body Embolism; Stroke/CVA

  MAUDE report 11684742 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2021-00198, 3008452825-2021-00172, 3008452825-2021-00170, 3005334138-2021-00197, 2184149-2021-00099. SEVERAL HOURS FOLLOWING A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. FOLLOWING THE PROCEDURE, WHILE USING THE ENSITE X IN VOXEL MODE A PERICARDIAL EFFUSION WAS DETECTED. DURING THE PROCEDURE, THE PATIENT WAS IN STABLE CONDITION AND THE PVI WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES. SEVERAL HOURS AFTER THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE, AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE CAUSE AND LOCATION OF THE EFFUSION REMAINS UNKNOWN. PER THE PHYSICIAN, THE REPORTED OVERSIZED SHELL INVOLVING THE ENSITE X MAY HAVE CONTRIBUTED TO THE EFFUSION. THE PATIENT IS CURRENTLY IN STABLE CONDITION AND HAS BEEN DISCHARGED.

  Patient problems: Cardiac Perforation

  MAUDE report 11585611 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REF: 2184149-2021-00091, 3008452825-2021-00175, 3008452825-2021-00177, 3005334138-2021-00202, 2184149-2021-00100. FOLLOWING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ECHOCARDIOGRAM. THE PERICARDIAL EFFUSION WAS TREATED SUCCESSFULLY AND THE PATIENT WAS STABILIZED, HOWEVER, IT IS UNKNOWN HOW IT WAS TREATED. THE PATIENT'S BLOOD PRESSURE WAS STABLE THROUGHOUT THE ENTIRETY OF THE PROCEDURE AND THERE WERE NO PERFORMANCE ISSUES WITH ANY DISPOSABLE DEVICES. PER THE PHYSICIAN, THE REPORTED OVERSIZED SHELL INVOLVING THE ENSITE X MAY HAVE CONTRIBUTED TO THE EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 11584546 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2021-00185, 3005334138-2021-00208, 34138-2021-00209, 3008452825-2021-00186, 2184149-2021-00101. FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE IN ENSITE X VOXEL MODE, A PERICARDIAL EFFUSION WAS DETECTED POSTERIOR RIGHT VENTRICLE. DURING THE PROCEDURE IT WAS DIFFICULT TO MANEUVER THE SHEATHS TOWARDS THE VENA CAVA. HOWEVER, THE LEFT PULMONARY VEINS WERE SUCCESSFULLY ABLATED. THE DECISION WAS THEN MADE TO STOP THE PROCEDURE DUE TO THE MANEUVERING DIFFICULTIES. THE PATIENT WAS IN CONSCIOUS SEDATION AND HAD A STABLE BLOOD PRESSURE. AT THE END OF THE PROCEDURE, A PERICARDIAL EFFUSION WAS DETECTED WITH NO INTERVENTION REQUIRED. THE BLOOD PRESSURE STABILIZED, THE PATIENT RECOVERED AND WAS DISCHARGED. PER THE PHYSICIAN, THE REPORTED OVERSIZED SHELL INVOLVING THE ENSITE X MAY HAVE CONTRIBUTED TO THE EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 11582365 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2021-00175, 3008452825-2021-00182 DURING A LEFT SIDED PULMONARY VEIN CONTRACTION PROCEDURE, A TAMPONADE OCCURRED. THE PATIENT BECAME HYPOTENSIVE, ADRENALINE WAS ADMINISTERED AND THE PATIENTS BLOOD PRESSURE INCREASED ONLY TRANSIENTLY. AN ECHO WAS REVEALED A CARDIAC PERFORATION AND THE PATIENT WAS TAKEN TO SURGERY, HOWEVER, THE SITE OF THE PERFORATION COULD NOT BE LOCATED. THE PATIENT IS RECOVERING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 11568534 ↗
• MalfunctionMar 16, 2021Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  DURING THE PROCEDURE, DIFFICULTIES PLACING THE CATHETER IN THE CORONARY VEIN WERE NOTED AND WHEN REMOVING THE CATHETER FROM THE PATIENT, EXPOSED WIRES WERE NOTED NEAR THE TIP OF THE CATHETER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 11497495 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 3008452825-2020-00300. DURING AN ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. WHILE ABLATING IN TO THE RIGHT VENTRICULAR OUTFLOW TRACT, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 10249926 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 2182269-2020-00050, 3008452825-2020-00256, 3008452825-2020-00257, 2182269-2020-00051. DURING VENTRICULAR TACHYCARDIA MAPPING IN THE LEFT VENTRICLE, A PERICARDIAL EFFUSION OCCURRED. AFTER APPROXIMATELY AN HOUR OF MAPPING, USING TRANSSEPTAL APPROACH, THE PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS ADMINISTERED. AN ADDITIONAL ULTRASOUND CONFIRMED A HEMOTHORAX ON THE LEFT SIDE OF THE THORAX, WHICH WAS TREATED WITH A THORAX DRAIN. THE CAUSE AND LOCATION OF THE PERICARDIAL EFFUSION REMAINS UNKNOWN, HOWEVER IT WAS NOTED THE TRANSSEPTAL PUNCTURE WAS DIFFICULT. THE PATIENT WAS STABLE WITH MINIMAL USE OF CATECHOLAMINES AND TRANSFERRED TO THE ICU. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Hemothorax

  MAUDE report 10098836 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REF: 2030404-2020-00015. DURING AN ATRIAL ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. WHILE MAPPING THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. THE EFFUSION DID NOT REQUIRE INTERVENTION AND THE PATIENT IS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9779285 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2020-00091, 3005334138-2020-00055, 3008452825-2020-00092. DURING AN ATRIAL TACHYCARDIA AND ATRIAL FIBRILLATION ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. WHILE MAPPING WITH THE ABLATION CATHETER IN THE LEFT ATRIUM, PRIOR TO ABLATION, THE PATIENT BECAME UNRESPONSIVE AND HYPOTENSIVE. A PERICARDIAL EFFUSION WAS OBSERVED USING ECHOCARDIOGRAPHY. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT; HOWEVER, CARDIOPULMONARY RESUSCITATION WAS NEEDED AND WAS TRANSFERRED TO SURGERY. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9738948 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3005334138-2019-00527, 3005334138-2019-00528, 2030404-2019-00095, 2030404-2019-00097. FOLLOWING AN ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. TWO HOURS FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED SLIGHT DIZZINESS. ECHOCARDIOGRAPHY DIAGNOSED AN EFFUSION APPROXIMATELY 15 MM CIRCULAR IN THE FRONT OF THE RIGHT ATRIUM AND RIGHT VENTRICLE. A PERICARDIAL EFFUSION WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9097472 ↗
• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 9097466 ↗
• InjuryAug 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00421, 3005334138-2019-00422, 3008452825-2019-00386, 3008452825-2019-00387. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING GEOMETRY COLLECTION AND ABLATION OF THE RIGHT-SIDED UPPER PULMONARY VEIN, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED AN EFFUSION. A TAMPONADE WAS DIAGNOSED AND A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 8876570 ↗
• InjuryAug 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PULMONARY VEIN ISOLATION (PVI) PROCEDURE, THE CATHETER WAS DIFFICULT TO MANEUVER DURING INSERTION AND A DISSECTION OCCURRED IN THE CORONARY SINUS OSTIUM. THE DISSECTION WAS DIAGNOSED USING FLUOROSCOPY AND NO INTERVENTION WAS PERFORMED. THE PHYSICIAN BELIEVED THE DISSECTION WAS DUE TO PATIENT ANATOMY. ANOTHER CATHETER WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 8870379 ↗
• MalfunctionJul 30, 2019Contamination; Contamination

  DURING AN ABLATION PROCEDURE, FOREIGN MATERIAL WAS OBSERVED ON THE CATHETER. FOLLOWING INSERTION WITHIN THE PATIENT THE CATHETER WAS WITHDRAWN AND A FOREIGN MATERIAL WAS NOTED ON THE TIP. THE CATHETER WAS REPLACED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841724 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00041, 3008452825-2019-00042, 3008452825-2019-00044, 3005334138-2019-00050, 3005334138-2019-00051, 3008452825-2019-00045, 3005334138-2019-00052. FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED VIA ECHOCARDIOGRAPHY. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. NO PATIENT SYMPTOMS WERE NOTED THROUGHOUT THE PROCEDURE AND THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8304838 ↗