Inquiry™ IBI-81172Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05414734303354), received between Feb 6, 2020 and Nov 10, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA RADIOFREQUENCY PROCEDURE, THERE WAS A DELAY. THE CATHETER COULD NOT BE INSERTED INTO THE PATIENT'S CORONARY SINUS. AFTER REMOVAL, IT WAS NOTED THAT THE TIP OF THE CATHETER WOULD NOT BEND. THE CATHETER WAS REPLACED AND THAT ISSUE WAS RESOLVED. IN ADDITION, THE SHEATH WAS BENT CLOCKWISE TO ALIGN WITH THE AXIS OF ROTATION. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511467 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MFR NUMBERS: 2184149-2020-00228, 3008452825-2020-00713, 3005334138-2020-00643, 3008452825-2020-00715. THE DAY FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. THE EFFUSION WAS FOUND DURING POST-PROCEDURE TRANSTHORACIC ECHOCARDIOGRAPHY PERFORMED ONE DAY AFTER THE PROCEDURE. THE LOCATION OF THE PERFORATION WAS NOT KNOWN. PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ALLEGATIONS AGAINST ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 11132770 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2020-0723, 3008452825-2020-00724, 3005334138-2020-00646, 3008452825-2020-00725. TWO DAYS POST ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED VIA TRANSTHORACIC ECHOCARDIOGRAPHY. SEROHEMATIC FLUID WAS DRAINED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 11060803 ↗
• InjuryFeb 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 2184149-2020-00014, 3008452825-2020-00066. DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A CANCELLATION, TAMPONADE AND SUBSEQUENT DEATH OCCURRED. THE CS CATHETER AND THE HIS CATHETER WERE INTRODUCED VIA THE FEMORAL VEIN INTO THE CORONARY SINUS AND AT THE HIS BUNDLE. DURING INTRODUCTION, EXCESSIVE CATHETER MOVEMENT WAS OBSERVED. A FLEXIBILITY WAS INTRODUCED VIA RETROGRADE ACCESS INTO THE AORTA, AND THE LATMAP AND A GEOMETRY OF THE LVOT WAS COLLECTED. SYSTEM REFERENCE AND RESPIRATION COMPENSATION WERE UTILIZED AND THE UPDATE RESPIRATION WAS OFF. ABLATION WAS STARTED AT THE EARLIEST POINT IN THE LVOT. DUE TO THE CATHETER MOVEMENT, THE CS 5 WAS UTILIZED FOR REFERENCE. FLOURO WAS NOT USED TO LOCATE THE CATHETERS FOLLOWING THE SHIFT. DURING PREPARATION OF CHANGING FROM ARTERIAL ACCESS TO VENOUS ACCESS THE PHYSICIAN NOTICED ABNORMAL STEERING OF THE FLEXIBILITY. FOLLOWING ABLATION IN THE LVOT, THERE WERE STILL PVCS. THE VISUALIZATION OF THE ABLATION CATHETER WAS NOT IN THE CORRECT LOCATION, AND SYSTEM REFERENCE WAS UTILIZED AND A SHIFT OCCURRED. THE CS SHADOW AND CURRENT CS POSITION WERE NOT ALIGNED. THE PHYSICIAN DECIDED TO GO IN RVOT AND A FLEXIBIL

  Patient problems: Cardiac Perforation; Death

  MAUDE report 9677260 ↗