Inquiry™ IBI-81594Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05414734305006), received between Sep 14, 2018 and Jul 13, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 13, 2023Fracture; Fracture

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, THE INQUIRY AFOCUS II CATHETER WAS PUSHED ABNORMALLY AND THE SHEATH WAS STUCK CAUSING THE RING ELECTRODE TO SEPARATE FROM THE SHAFT WHEN IT THE INQUIRY AFOCUS II CATHETER WAS PULLED OUT. THE INQUIRY AFOCUS II CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17319184 ↗
• MalfunctionMar 28, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS REPORT IS TO ADVISE OF BURN DAMAGE ON THE SHAFT OF THE CATHETER NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16627986 ↗
• MalfunctionSep 24, 2022Fracture; Fracture

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER WAS INSERTED THROUGH AN SL1 INTRODUCER AND INTO THE RIGHT ATRIUM. WHEN ATTEMPTING TO INSERT THE CATHETER, IT COULD NOT BE ADVANCED INTO THE INTRODUCER. UPON REMOVAL, THE CATHETER WAS NOTED TO BE FRACTURED. 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 15477375 ↗
• MalfunctionMay 7, 2022Signal Artifact/Noise; Display or Visual Feedback Problem; Signal Artifact/Noise; Display or Visual Feedback Problem

  RELATED MANUFACTURING REF: 3008452825-2022-00410. DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, INTERFERENCE WAS NOTED WHICH CAUSED A DELAY. SIGNAL INTERFERENCE WAS NOTED DURING THE PROCEDURE AND THE FOURTH ELECTRODE APPEARED DISTORTED IN THE SYSTEM. AFTER MULTIPLE ATTEMPTS OF CATHETER INTRODUCTION AND WITHDRAWAL, THE CATHETER STILL APPEARED DISTORTED IN THE SYSTEM. ANOTHER CATHETER WAS USED WHICH HAD THE SAME ISSUE. A THIRD CATHETER WAS USED TO CONTINUE THE PROCEDURE, HOWEVER THIS CAUSED A DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14319700 ↗
• MalfunctionFeb 28, 2022Material Separation; Material Separation

  THIS REPORT IS TO ADDRESS THE INVESTIGATION FINDINGS OF A MISSING ELECTRODE ON THE CATHETER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13618817 ↗
• MalfunctionJan 26, 2022Fracture; Difficult to Remove; Fracture; Difficult to Remove

  DURING AN ATRIAL TACHYCARDIA ABLATION PROCEDURE, THE CATHETER WAS DIFFICULT TO PULL BACK OUT OF THE SHEATH. UPON REMOVAL, THE CATHETER WAS NOTED TO BE FRACTURED BETWEEN ELECTRODES 4 AND 5. 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 13360512 ↗
• MalfunctionJul 22, 2021Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER BECAME STUCK IN THE SL1 SHEATH. THE CATHETER WAS CAREFULLY REMOVED, BUT WAS FRACTURED WITH EXPOSED WIRES. THE CATHETER WAS EXCHANGED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211442 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 3005334138-2020-00465, 2182269-2020-00087, 3005334138-2020-00466, 3008452825-2020-00521. AT THE END OF A PVC ABLATION PROCEDURE, DURING RF OF THE LAST LESION, A PERICARDIAL EFFUSION OCCURRED. THE DUO CATHETER WAS PLACED IN THE CORONARY SINUS AND THE FLEXABILITY WAS USED FOR ABLATION OF THE PVC'S IN THE RIGHT VENTRICLE. REINFORCEMENT OF THE LESIONS IN THE RIGHT VENTRICLE WERE VERIFIED TO CONFIRM ELIMINATION OF THE ARRHYTHMIA. HOWEVER, 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 10669306 ↗
• InjuryFeb 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 2182269-2019-00017, 3008452825-2019-00075, 3005334138-2019-00090. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT EXPERIENCED A STROKE. IN THE RECOVERY ROOM, A CROOKED MOUTH AND FAILURE TO RESPOND WAS NOTED IN THE PATIENT. A STROKE WAS SUSPECTED AND THE PATIENT WAS TRANSFERRED TO ANOTHER CENTER AND WAS FOLLOWED. THE CAUSE OF THE STROKE IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

  Patient problems: Stroke/CVA

  MAUDE report 8350449 ↗
• MalfunctionSep 14, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED UPON RECEIPT SHOWING DISPLACED ELECTRODES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877056 ↗