Inquiry™ IBI-81404Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05414734304146), received between Dec 19, 2018 and Jan 31, 2022 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CRYO ATRIAL FIBRILLATION PROCEDURE, AN EFFUSION OCCURRED IN THE LEFT ATRIUM. THE PHYSICIAN HAD CRYO ABLATED THE LEFT VEINS AND WAS MOVING THE IBI QUAD INTO THE SVC FOR PHRENIC PACING TO BEGIN CRYO ABLATION OF THE RIGHT VEINS WHEN THE ANESTHESIA TEAM NOTICED A DROP IN THE PATIENT¿S BLOOD PRESSURE. AN ULTRASOUND CONFIRMED THE PERICARDIAL EFFUSION. THE PATIENT CODED ON THE TABLE AND WAS RUSHED TO EMERGENCY SURGERY AND A PERICARDIOCENTESIS WAS PERFORMED. THE CURRENT PATIENT STATUS IS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 13391840 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE # 3008452825-2020-00386, 2030404-2020-00056. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. AFTER PLACING THE CORONARY SINUS AND RIGHT VENTRICLE CATHETERS, CARDIOVERSION WAS CONDUCTED. FOLLOWING CARDIOVERSION, THE BLOOD PRESSURE WAS NOTED TO BE LOWER IN THE SINUS RHYTHM AND FLUIDS WERE GIVEN. THE PERICARDIAL SPACE WAS THEN ASSESSED WHICH REVEALED A PERICARDIAL EFFUSION. THE BLOOD PRESSURE THEN ROSE TO AN ACCEPTABLE LEVEL AND THE PROCEDURE WAS COMPLETED. AN EFFUSION REMAINED POST ECHOCARDIOGRAM, HOWEVER THE PATIENT WAS DEEMED STABLE AND NO FURTHER ACTION WAS TAKEN.

  Patient problems: Cardiac Perforation

  MAUDE report 10422208 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WITH THE INQUIRY CATHETER IN THE CORONARY SINUS. THE PATIENT IS RECOVERING.

  Patient problems: Cardiac Perforation

  MAUDE report 9602993 ↗
• InjuryAug 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00404, 3008452825-2019-00407, 2182269-2019-00113. DURING AN ATRIAL FIBRILLATION AND ATRIAL FLUTTER ABLATION PROCEDURE A DISSECTION OCCURRED. DURING THE PROCEDURE, AS THE PHYSICIAN WAS GUIDING THE DEVICES THROUGH A NARROW LEFT ILIAC VEIN, THE PATIENT BECAME HYPOTENSIVE. A HEMOGLOBIN TEST WAS RUN AND IT WAS DETERMINED THE PATIENT NEEDED A BLOOD TRANSFUSION. CONTRAST WAS INJECTED TO DETERMINE THE LOCATION OF THE BLEEDING AND A DISSECTION WAS FOUND. VASCULAR INTERVENTION WAS NOT REQUIRED AS THE DISSECTION CLOSED ON ITS OWN. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 8883520 ↗
• 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, 3008452825-2019-00385, 3008452825-2019-00386. 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 8876583 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00358, 2182269-2019-00099, 2182269-2019-00100, 2030404-2019-00058. DURING A PULMONARY VEIN CONTRACTION (PVC) ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. FOLLOWING ABLATION OF THE RIGHT CORONARY CUSP, THE USER ATTEMPTED A SECOND PVC IN THE LEFT VENTRICLE (LV) THROUGH THE CORONARY SINUS (CS). A FLEXIBILITY CATHETER WAS USED FIRST THROUGH AN AGILIS SHEATH BUT THERE WAS NO SUCCESS IN REACHING THE TARGET SITE. A SAFIRE CATHETER WAS THEN ATTEMPTED BUT IT WAS DECIDED THE ANATOMY OF THE PATIENT WAS TOO DIFFICULT TO PLACE A CATHETER OUT DISTALLY IN THE CS. THE USER DECIDED TO FORGO FURTHER ABLATION AND PROCEEDED WITH AN EP STUDY. DURING THE EP STUDY THE PATIENT BECAME HYPOTENSIVE AND ECHOCARDIOGRAPHY CONFIRMED FLUID IN THE PERICARDIUM NECESSITATING A PERICARDIOCENTESIS. ONCE STABILIZED THE PATIENT WAS TRANSFERRED OUT OF THE OPERATING ROOM. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8821471 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00271, 3005334138-2019-00303. DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. WHILE ABLATING ALONG THE RIGHT VENTRICULAR OUTFLOW TRACT AT 40 WATTS IN TEMPERATURE CONTROL MODE, A STEAM POP OCCURRED. ABLATION WAS STOPPED AND THE PATIENT WAS MONITORED. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. THE PATIENT WAS TRANSFERRED IN STABLE CONDITION FOR MONITORING AND BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8686952 ↗
• MalfunctionMay 24, 2019Material Rupture; Material Rupture

  ANOTHER CATHETER FROM THE SAME MODEL WAS USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641118 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2019-00062. DURING A CRYO ABLATION, A PERICARDIAL EFFUSION WAS NOTED. FOLLOWING TRANSSEPTAL PUNCTURE, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAPH WAS PERFORMED CONFIRMING AN EFFUSION. THE PATIENT WAS MONITORED AND TRANSFERRED TO THE CICU AND NEO-SYNEPHRINE WAS ADMINISTERED. THE EFFUSION WAS LOCATED ON THE RIGHT LATERAL WALL OF THE RIGHT ATRIA. THE CAUSE OF THE EFFUSION WAS UNKNOWN. THE PATIENT WAS FOLLOWED AND STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8323415 ↗
• InjuryJan 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A CRYO BALLOON ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION A PERICARDIAL EFFUSION OCCURRED. POST-PROCEDURE, FOLLOWING CATHETER REMOVAL, THE PATIENT BECAME HYPOTENSIVE. AN EFFUSION WAS DIAGNOSED VIA ECHOGRAPHY. PERICARDIOCENTESIS AND CPR WERE BOTH PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS THEN TRANSFERRED TO THE OPERATING ROOM IN ORDER TO SUTURE A PERFORATION IN THE RIGHT VENTRICLE. THE PATIENT WAS STABILIZED AND IS RECOVERING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8208066 ↗
• InjuryDec 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBER: 3005334138-2018-00489, 3008452825-2018-00417, 3008452825-2018-00419, 3005334138-2018-00498, 3005334138-2018-00497 DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED. ONE HOUR FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8182502 ↗