Inquiry™ IBI-81102Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05414734302968), received between Aug 8, 2018 and Sep 10, 2025 — classified as 2 injuries, 14 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Difficult to Insert; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Difficult to Insert; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, DIFFICULTY WITH POSITIONING THE CATHETER INTO THE CORONARY SINUS RESULTED IN A PROCEDURAL DELAY. THE CATHETER WAS SHAPED MANY TIMES; HOWEVER, IT WAS STILL NOT POSSIBLE TO MAKE THE CATHETER REACH THE APPROPRIATE POSITION. THE CATHETER WAS REPLACED BUT THE RESULT WAS THE SAME. BOTH CATHETERS COULD NOT GET TO THE DEEPER POSITION OF THE CORONARY SINUS AFTER LOSING BENDS. THE PROCESS LASTED ALMOST TWO HOURS. THE SECOND CATHETER WAS REPLACED WITH A NON-ABBOTT DEVICE (SYNAPTIC MEDICAL STEERABLE EP CATHETER) WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020524 ↗
• MalfunctionSep 10, 2025Difficult to Insert; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem; Difficult to Insert; Improper or Incorrect Procedure or Method; Activation, Positioning or Separation Problem

  DURING THE PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) PROCEDURE, DIFFICULTY WITH POSITIONING THE CATHETER INTO THE CORONARY SINUS RESULTED IN A PROCEDURAL DELAY. THE CATHETER WAS SHAPED MANY TIMES; HOWEVER, IT WAS STILL NOT POSSIBLE TO MAKE THE CATHETER REACH THE APPROPRIATE POSITION. THE CATHETER WAS REPLACED BUT THE RESULT WAS THE SAME. BOTH CATHETERS COULD NOT GET TO THE DEEPER POSITION OF THE CORONARY SINUS AFTER LOSING BENDS. THE PROCESS LASTED ALMOST TWO HOURS. THE SECOND CATHETER WAS REPLACED WITH A NON-ABBOTT DEVICE (SYNAPTIC MEDICAL STEERABLE EP CATHETER) WHICH RESOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020130 ↗
• MalfunctionAug 11, 2025Use of Device Problem; Use of Device Problem

  THIS REPORT IS TO ADVISE OF A CATHETER USED IN THE PATIENT PAST THE EXPIRATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22774590 ↗
• MalfunctionMar 25, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PREMATURE VENTRICULAR CONTRACTIONS (PVC) PROCEDURE IN THE RIGHT VENTRICLE (RV), NOISE ISSUES WITH THE EP CATHETER RESULTED IN A PROCEDURAL DELAY. THE CS CATHETER EGMS WERE NOISY AND THEN IMPROVED SOME. THE CS CATHETER WAS LEFT IN THE RA/SVC JUNCTION. MULTIPLE PVCS WERE OBSERVED SO THE MAPPING CATHETER WAS INSERTED INTO THE RIGHT ATRIUM (RA) TO PREPARE FOR MAPPING. EGMS ON THE MAPPING CATHETER WERE NOISY AS WELL. ALL CONNECTIONS WERE CHECKED. THE MAPPING CATHETER CABLE WAS REPLACED BUT THE ISSUE PERSISTED. THE CLARIS AND ENSITE WERE TURNED OFF AND ON AGAIN BUT THE NOISE ISSUE CONTINUED. ALL ECG CONNECTIONS WERE CHECKED AND THE RL AND RA PATCHES WERE REPLACED AND CHANGED TO CLARIS ECG ONLY BUT THE ISSUE WAS NOT RESOLVED. RETURNED TO ENSITE ECG AND REPLACED THE MAPPING CATHETER BUT STILL NO IMPROVEMENT. THE PHYSICIAN MOVED THE MAPPING CATHETER INTO THE RIGHT RV AND THE NOISE ISSUE WAS RESOLVED. AFTER ABLATION WAS COMPLETED, THE PHYSICIAN PULLED THE MAPPING CATHETER BACK INTO THE RA AND THE NOISE RETURNED. ON FLUOROSCOPY, THE MAPPING CATHETER WAS ADJACENT TO THE CS CATHETER SO IT IS THOUGHT THAT MAYBE THE NOISE ISSUE IS RELATED TO THE CS CATHETER. THE PROCEDURE WAS COMPLETED W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689331 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER SHAFT DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643947 ↗
• MalfunctionNov 10, 2023Fracture; Fracture

  DURING AN ATRIOVENTRICULAR NODAL REENTRANT PROCEDURE, THE CATHETER WAS REMOVED AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO CANNULATE THE CORONARY SINUS AND A FRACTURED TIP WAS NOTED. ADDITIONALLY, THE CATHETER DID NOT STEER AS EXPECTED. 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 18112609 ↗
• MalfunctionApr 25, 2023Material Deformation; Material Deformation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, IT WAS NOTED THAT THE PROXIMAL ELECTRODES 7-8 AND 9-10 HAD NO PHYSICAL SPACING. NO ANOMALIES WERE NOTED PRIOR TO INSERTION, AND THE CATHETER ELECTRODE SPACING WAS DISPLAYING CORRECTLY ON THE MAPPING SYSTEM. THERE WERE NO DIFFICULTIES REMOVING OR INSERTING THE CATHETER THROUGH THE INTRODUCER. THE SIZE USED WAS 7F. THE DEVICE WAS NOT REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16806846 ↗
• MalfunctionMar 16, 2023Signal Artifact/Noise; Fracture; Signal Artifact/Noise; Fracture

  ADDITIONAL INFORMATION RECEIVED FROM THE REP STATED THIS ISSUE WAS NOT VISIBLE IN THE LAB AND LIKELY OCCURRED DURING SHIPPING. THEREFORE, THIS IS NOT A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553239 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3005334138-2023-00041, 3005334138-2023-00042, 3005334138-2023-00043, 2184149-2023-00034. DURING A REDO ATRIAL FIBRILLATION PROCEDURE, THE PATIENT COMPLAINED OF CHEST PAIN AND AN X-RAY AND ULTRASOUND REVEALED A PERICARDIAL EFFUSION IN THE RIGHT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PHYSICIAN SAID THAT DURING DRAINAGE, THE BLOOD APPEARED TO BE DARK / NON-OXYGENATED, INDICATING THAT THE PERICARDIAL EFFUSION WAS MOST LIKELY ORIGINATING FROM THE RIGHT ATRIUM AND THAT THE CS CATHETER COULD POTENTIALLY HAVE BEEN THE REASON BEHIND IT. THE PATIENT DID NOT RECEIVE ANY RF APPLICATIONS.

  Patient problems: Cardiac Perforation

  MAUDE report 16337172 ↗
• MalfunctionDec 23, 2022Entrapment of Device; Entrapment of Device

  DURING PROCEDURE, THE CATHETER BECAME STUCK WITHIN THE HEART ANATOMY AND A SNARE WAS USED TO REMOVE THE CATHETER WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. DURING AN INTERVENTIONAL CATHETERIZATION PROCEDURE, IT WAS DECIDED TO PERFORM AN AV NODE CONDUCTION ASSESSMENT USING THE CATHETER FOR PACING. IT WAS NOTED THAT THE CATHETER BECAME STUCK IN THE FENESTRATION BAFFLE SO IT HAD TO BE CUT AT THE HANDLE AND RETRIEVED USING A SNARE. IT WAS CLAIMED THAT THE CATHETER, RIGHT BEFORE IT GOT STUCK, LOOKED BENT UNDER FLUOROSCOPY AND IT WAS NOT POSSIBLE TO UNDO THE CURVE FROM THE HANDLE AS USUAL. NO ADVERSE CONSEQUENCES FOR THE PATIENT AFTER THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16042461 ↗
• MalfunctionOct 26, 2021Material Deformation; Patient Device Interaction Problem; Material Deformation; Patient Device Interaction Problem

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING DISPLACED ELECTRODES ON THE CATHETER AND A FORMATION OF A BIOLOGICAL SUBSTANCE ON THE TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12696978 ↗
• MalfunctionMar 5, 2021Difficult to Remove; Difficult to Remove

  DURING THE PROCEDURE, THE CATHETER BECAME CAUGHT DURING REMOVAL FROM THE NON ABBOTT INTRODUCER. THE CATHETER COULD NOT BE USED AS DIFFICULTIES WERE ENCOUNTERED WHEN ATTEMPTING TO REMOVE IT FROM THE SHEATH. THE INTRODUCER AND CATHETER WERE REMOVED TOGETHER. AN ADDITIONAL ACCESS SITE PUNCTURE WAS REQUIRED AND THE PROCEDURE CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11424573 ↗
• MalfunctionMar 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DISPLACED ELECTRODE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8432705 ↗
• MalfunctionJan 25, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A DISPLACED ELECTRODE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8277757 ↗
• MalfunctionAug 29, 2018Material Twisted/Bent; Material Twisted/Bent

  DURING THE PROCEDURE, THE SURFACE OF THE CATHETER WAS TWISTED, EXPOSING THE WIRE. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7828600 ↗
• InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 9680001-2018-00112, 3008452825-2018-00260, 2030404-2018-00054. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED IN THE LEFT ATRIUM. DURING THE PROCEDURE, GEOMETRY OF THE LEFT ATRIUM WAS CREATED AND THE LEFT PULMONARY VEINS WERE SUCCESSFULLY ISOLATED. WHILE ISOLATING THE RIGHT PULMONARY VEINS, THE INTRODUCER SHEATH SHIFTED TO THE RIGHT ATRIUM, TOGETHER WITH THE ABLATION CATHETER. WHILE REPOSITIONING THE INTRODUCER SHEATH, THE PATIENT¿S VITALS WENT DOWN. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A TAMPONADE. A DRAIN WAS SUCCESSFULLY PLACED, BUT VITALS REMAINED LOW. CARDIOPULMONARY RESUSCITATION WAS PERFORMED ALTHOUGH THE PATIENT STILL HAD RHYTHM. THE PATIENT WAS TRANSFERRED TO SURGERY FOR REPAIR AND IS IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 7761993 ↗