Inquiry™ AFocus II™ IBI-87008Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 05414734309929), received between Jun 19, 2018 and Jun 16, 2025 — classified as 10 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2025Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE DISTAL ELECTRODE OF THE MAPPING CATHETER DETACHED. WHEN ATTEMPTING TO WITHDRAW THE CATHETER THROUGH THE SHEATH, IT BECAME ENTRAPPED AND RESISTANCE WAS FELT. THE CATHETER SIGNAL WAS POOR AND WHEN THE CATHETER WAS REMOVED IT WAS NOTED THAT THE DISTAL ELECTRODE HAS BECOME DETACHED. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED. IT IS UNKNOWN WHETHER THE DETACHED ELECTRODE WAS SUCCESSFULLY RETRIEVED OR REMAINS WITHIN THE PATIENT. THE ELECTRODE FRAGMENT WAS NOT VISUALIZED EXTERNALLY. FLUOROSCOPIC IMAGING WAS REVIEWED IN AN ATTEMPT TO LOCATE THE ELECTRODE FRAGMENT, BUT DEFINITIVE CONFIRMATION OF ITS PRESENCE OR ABSENCE IN THE PATIENT COULD NOT BE OBTAINED AT THE TIME OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22216700 ↗
• MalfunctionApr 9, 2024Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A FRACTURE WAS NOTED ON THE INQUIRY AFOCUS MAPPING CATHETER. TRANSSEPTAL PUNCTURE WAS COMPLETED, AND MAPPING WAS DONE WITH AN INQUIRY AFOCUS MAPPING CATHETER. WHEN THE INQUIRY AFOCUS MAPPING CATHETER WAS REMOVED FROM THE PATIENT IT WAS NOTED THAT THE OUTER COVERING WAS FRACTURED ON THE TIP OF THE CATHETER WAS ONLY RETAINED BY A METALLIC CABLE. ABLATION WAS THEN COMPLETED USING THE TACTICATH ABLATION CATHETER WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068854 ↗
• MalfunctionJan 9, 2024Fracture; Fracture

  RELATED MANUFACTURING REFERENCE: 3008452825-2024-00003. DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK OCCURRED WITH THE INTRODUCER. THE INTRODUCER WAS REPLACED TO COMPLETE THE PROCEDURE. ALSO DURING THIS PROCEDURE, DEFLECTION ISSUES WERE NOTED WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CATHETER WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. UPON REMOVAL, A PHYSICAL BREAK WAS NOTED ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18475948 ↗
• InjuryJan 3, 2024Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  DURING THE ATRIAL FIBRILLATION ABLATION PROCEDURE IN THE ANATOMY CONSTRUCTION STAGE, THE CATHETER BECAME TRAPPED IN THE CHORDAE TENDINEAE OF THE MITRAL VALVE. THE SURGEON PERFORMED MANEUVERS IN AN ATTEMPT TO LOOSEN THE CATHETER, HOWEVER, FRACTURE AND DETACHMENT OF THE DISTAL PART OF THE CATHETER BODY OCCURRED. PATIENT UNDERWENT CARDIAC SURGERY TO REMOVE THE FRAGMENT. PATIENT STABLE ACCORDING TO ATTENDING PHYSICIAN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18434834 ↗
• MalfunctionMay 5, 2023Fracture; Difficult to Remove; Fracture; Difficult to Remove

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A FRACTURE OF THE DEVICE OCCURRED. THE CATHETER WAS UNABLE TO DEFLECT AND RESISTANCE WAS NOTED WHEN ATTEMPTING TO REMOVE IT. THE CATHETER WAS REMOVED AFTER MULTIPLE ATTEMPTS; HOWEVER, THE OUTER COATING OF THE CATHETER SHAFT HAD FRACTURED. NO REMNANTS OF THE CATHETER WERE BELIEVED TO BE LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876128 ↗
• MalfunctionJun 16, 2022Entrapment of Device; Activation, Positioning or Separation Problem; Entrapment of Device; Activation, Positioning or Separation Problem

  DURING THE ATRIAL FIBRILLATION PROCEDURE, FOLLOWING INSERTION OF THE CATHETER INTO THE LEFT ATRIUM, THE LOOP PORTION OF THE CATHETER WAS CAUGHT ON THE STRAIGHT SHAFT AND COULD NOT BE REMOVED. ATTEMPTS TO STRAIGHTEN THE CATHETER AND REMOVE IT WERE UNSUCCESSFUL. THE CATHETER WAS ABLE TO BEND DEPENDING ON THE METHOD, BUT COULD NOT BE STRAIGHTENED. IT WAS ALSO NOTED THAT THE CATHETER COULD NOT BE INSERTED INTO THE SHEATH DUE TO STRONG FLEXION. THE CATHETER WAS PULLED OUT FROM THE LEFT ATRIAL SEPTUM TO THE RIGHT ATRIUM, AND THE LOOP WAS NOT ENTANGLED. THE CATHETER WAS TAKEN IN AND OUT OR ROTATED MULTIPLE TIMES IN THE RIGHT ATRIUM, AND FINALLY IT COULD BE STORED IN THE SHEATH. WHEN CHECKED OUTSIDE THE BODY, THE CATHETER WAS NOTED TO BE BENT, COULD NOT BE STRAIGHTENED AND THE LOOP WAS ENTWINED. WHEN THE CATHETER WAS PULLED OUT FROM THE LEFT ATRIUM TO THE RIGHT ATRIUM, THE LOOP REMAINED ENTWINED WITH A POSSIBLE ATRIAL SEPTAL DEFECT (ASD). THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14713710 ↗
• MalfunctionApr 15, 2022Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER SHAFT WAS NOTED TO BE TORN / FRACTURED. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT HEALTH CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118939 ↗
• MalfunctionMar 28, 2022Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  DURING THE PROCEDURE, A DEVICE FRACTURE OCCURRED. THE DEVICE WAS DIFFICULT TO MANEUVER NEAR THE END OF THE PROCEDURE; THE EXTERIOR LOOP WAS STUCK AS IT WAS NOTED TO BE CROOKED AT THE SHAFT. UPON REMOVAL OF THE CATHETER, A FRACTURE WAS NOTED. AN ABLATION CATHETER WAS USED INSTEAD OF THE AFOCUS TO CHECK VEINS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929659 ↗
• MalfunctionFeb 9, 2022Fracture; Fracture

  DURING THE RE-MAP PHASE AT THE END OF THE PROCEDURE, THE CATHETER BECAME ENTANGLED IN THE LEFT ATRIUM AND RUPTURED. WHEN TRYING TO UNTANGLE THE CATHETER, IT PARTIALLY RUPTURED. ONCE THE CATHETER WAS DEBRIDED, IT WAS REMOVED NORMALLY AS IT COULD PASS THROUGH THE INTRODUCER AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13501666 ↗
• MalfunctionJan 27, 2022Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE DIAGNOSTIC CATHETER BECAME STUCK ON ITSELF. DUE TO SUCH, IT WAS NOT POSSIBLE TO GET THE DIAGNOSTIC CATHETER BACK INTO THE SHEATH. THE CATHETER WAS REMOVED BY PULLING OUT THE SHEATH WITH THE CATHETER STILL STICKING OUT THE DISTAL PORTION OF THE SHEATH. FOLLOWING THE REMOVAL OF THE CATHETER, THE CATHETER WAS FOUND TO BE KINKED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366065 ↗
• MalfunctionJan 21, 2022Fracture; Fracture

  DURING THE CONSTRUCTION OF 3D GEOMETRY IN THE LEFT ATRIUM, A FRACTURE WAS NOTED IN THE DISTAL REGION 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

  MAUDE report 13315781 ↗
• MalfunctionJul 12, 2021Material Frayed; Peeled/Delaminated; Material Frayed; Peeled/Delaminated

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE CATHETER'S BLUE SHAFT PEELED OFF WHILE INSIDE THE INTRODUCER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12149955 ↗
• MalfunctionApr 15, 2021Material Frayed; Material Frayed

  DURING THE PROCEDURE, AFTER APPROXIMATELY TWO HOURS OF MANIPULATION OF THE CATHETER WHILE IN THE LEFT ATRIUM AND SEVERAL INSERTION AND REMOVALS OF THE CATHETER FROM THE SHEATH, THE OUTER LAYER OF THE CATHETER WAS NOTED TO BE FRAYED AND THERE WERE EXPOSED WIRES. THE CATHETER WAS EXCHANGED TO RESOLVE THE ISSUE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WERE NO DIFFICULTIES NOTED DURING THE PROCEDURE DUE TO THE PATIENT'S ANATOMY AND NO INSERTION DIFFICULTIES OR REMOVAL DIFFICULTIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11674932 ↗
• MalfunctionNov 24, 2020Material Frayed; Difficult to Remove; Activation, Positioning or Separation Problem; Material Frayed; Difficult to Remove; Activation, Positioning or Separation Problem

  DURING THE PROCEDURE, AFTER THE CATHETER WAS USED IN THE LEFT ATRIUM AND WHEN ATTEMPTING TO PERFORM MAPPING IN THE RIGHT ATRIUM, THE CATHETER SUDDENLY STOPPED DEFLECTING. THE CATHETER WAS NOT STUCK IN THE VALVE. THE CATHETER WAS ATTEMPTED TO BE REMOVED FROM THE PATIENT; HOWEVER, IT COULD NOT BE REMOVED FROM THE 10F SL0 INTRODUCER. IT COULD BE FINALLY REMOVED AFTER PULLING BACK AND FORWARD WITH FORCE. WHEN THE CATHETER WAS CHECKED, A PART OF THE BLUE COATING WAS PEELED OFF AND THE WIRES WERE FOUND TO BE EXPOSED. THE CATHETER COULD BE DEFLECTED AFTER BEING REMOVED FROM THE PATIENT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10890044 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE MAPPING OF THE PAC, A PERICARDIAL EFFUSION OCCURRED. DURING THE MAPPING OF THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10669294 ↗
• MalfunctionSep 21, 2020Material Frayed; Activation, Positioning or Separation Problem; Material Frayed; Activation, Positioning or Separation Problem

  AT THE END OF THE PROCEDURE, THE CATHETER WAS REMOVED FROM THE PATIENT AND EXPOSED INTERNAL WIRING WAS NOTED. TO CHECK THE ISOLATION OF THE LOWER RIGHT PULMONARY VEIN AT THE END OF THE PROCEDURE, SEVERAL ROTATIONAL MOVEMENTS WERE MADE IN A CLOCKWISE DIRECTION IN SEQUENCE WITH THE CIRCULAR DOUBLE LOOP CATHETER. AFTER THE MANEUVERS, A DEFLECTION ISSUE WAS NOTED AND WHEN THE CATHETER WAS REMOVED FROM THE PATIENT, IT WAS VERIFIED THAT THE EXTERNAL INSULATION OF THE CATHETER WAS TORN AND PULLED APART. THE PROCEDURE WAS ALREADY COMPLETED WHEN THE ISSUE WAS NOTED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

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

  MAUDE report 10563902 ↗
• InjuryAug 14, 2020Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE MAPPING CATHETER BECAME ENTANGLED IN THE MITRAL VALVE. THE CATHETER WAS UNABLE TO BE REMOVED SO THE CATHETER WAS BROKEN INTO TWO PIECES TO BE REMOVED, WITH 5 CM OF THE DISTAL CATHETER REMAINING IN THE PATIENT. THE ABLATION PROCEDURE WAS STOPPED AND THE PATIENT WAS TAKEN INTO SURGERY WHERE THE REMAINING PORTION OF THE CATHETER WAS SURGICALLY REMOVED. THE PATIENT IS NOW IN STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10406781 ↗
• InjuryFeb 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2030404-2020-00012, 3008452825-2020-00112, 2182269-2020-00020, 2182269-2020-00021, 3008452825-2020-00113, 2182269-2020-00022, 3005334138-2020-00072. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AFTER THE PROCEDURE WAS COMPLETED, THE PATIENT BECAME HYPOTENSIVE, SO AN ULTRASOUND WAS PERFORMED, CONFIRMING A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9744993 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00665, 3008452825-2019-00663, 3008452825-2019-00666, 3005334138-2019-00992. FOLLOWING THE PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITHOUT ISSUE WITH TRANS-ESOPHAGEAL ULTRASOUND GUIDANCE. THE PROCEDURE WAS CARRIED OUT SUCCESSFULLY AND THE PATIENT WAS AWOKEN WITHOUT ANY HEMODYNAMIC INSTABILITY. AROUND 20 MINUTES FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. ULTRASOUND CONFIRMED A PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9539455 ↗
• MalfunctionDec 12, 2019Entrapment of Device; Entrapment of Device

  DURING THE PROCEDURE, THE AFOCUS CATHETER LOOP BECAME ENTANGLED AROUND THE INTRODUCER WHILE IN THE LEFT ATRIUM. THE ABLATION CATHETER WAS USED TO PULL ON THE AFOCUS AND RETRACT IT AT THE SAME TIME. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9457294 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00614, 43005334138-2019-00690. DURING LEFT ATRIAL GEOMETRY, THE PATIENT BECAME HYPOTENSIVE. A PERICARDIAL EFFUSION WAS CONFIRMED BY ULTRASOUND EXAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED.

  Patient problems: Cardiac Perforation

  MAUDE report 9443576 ↗
• MalfunctionSep 19, 2019Material Frayed; Material Frayed

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS REVEALING A MATERIAL SEPARATION / EXPOSED WIRES OF THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9086166 ↗
• InjuryMay 20, 2019Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, THE CATHETER BECAME LODGED IN THE PATIENT AND COULD NOT BE REMOVED. FOLLOWING MAPPING IN THE RIGHT ATRIUM, FLUOROSCOPY REVEALED THE CATHETER WOULD NOT MOVE AND COULD NOT BE REMOVED FROM THE INFERIOR CAVA. A TEE DID NOT DETERMINE WHERE THE CATHETER WAS LOCATED, AND THE PATIENT WAS TRANSFERRED TO SURGERY TO EXTRACT THE CATHETER VIA THE SUBCLAVIAN VEIN. THE PATIENT IS RECOVERING IN THE UCI.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8623564 ↗
• MalfunctionApr 30, 2019Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A TEAR IN THE CATHETER SHAFT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8564497 ↗
• MalfunctionApr 16, 2019Material Integrity Problem; Material Integrity Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE THE CATHETER WAS DIFFICULT TO PULL BACK INTO THE SHEATH AFTER MAPPING HAD BEEN PERFORMED. ONCE REMOVED THE CATHETER COATING WAS NOTED TO BE DETERIORATED/CUT. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517735 ↗