Inquiry™ IBI-81531Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05414734304788), received between Sep 14, 2018 and Mar 4, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  DURING AN ATRIAL FIBRILLATION PROCEDURE, AFTER PERFORMING TRANSSEPTAL PUNCTURE WITH A NON-ABBOTT FARADRIVE SHEATH AND VERSACROSS RF WIRE, THE PATIENT BECAME HYPOTENSIVE, AND A TAMPONADE WAS CONFIRMED. THE ICE CATHETER WAS POSITIONED IN THE RIGHT ATRIUM, AND THE CORONARY SINUS CATHETER WAS PLACED IN THE CORONARY SINUS. THE TRANSSEPTAL DEVICES WERE THEN ADVANCED INTO THE SVC. THE SEPTUM WAS CROSSED USING RF FROM THE VSX WIRE AND IT WAS NOT CERTAIN WHERE THE WIRE AND SHEATH WERE ADVANCING TO. THE STICK MAY HAVE BEEN TOO ANTERIOR. THE DEVICES WERE PULLED BACK TO THE RIGHT ATRIUM FOR A DIFFERENT TRANSSEPTAL POSITION, AND AFTER SEVERAL ATTEMPTS THE PATIENT'S PRESSURE BEGAN TO DROP. THE TAMPONADE WAS THEN SEEN ON ICE. A PERICARDIOCENTESIS WAS PERFORMED, STABILIZING THE PATIENT AND THE PROCEDURE WAS THEN STOPPED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES. THE PHYSICIAN ALLEGES THAT THE PERFORATION OCCURRED DURING TRANSSEPTAL PUNCTURE, EITHER WHERE THE SEPTUM WAS INITIALLY CROSSED, OR DURING POSITIONING OF THE NON-ABBOTT TRANSSEPTAL DEVICE WITH SEVERAL ATTEMPTS.

  Patient problems: Cardiac Perforation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511904 ↗
• MalfunctionMay 28, 2021Structural Problem

  ARTIFACT AT DISTAL END OF CATHETER. NO HARM TO PATIENT. PROCEDURE COMPLETED, UNKNOWN IF NEW CATHETER WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900574 ↗
• MalfunctionApr 7, 2021Defective Device

  DEFECTIVE CURVE COULDN'T PLACE CATHETER IN THE CORONARY SINUS. DIFFERENT CATHETER OPENED AND USED WITHOUT PROBLEM.

  Patient problems: Insufficient Information

  MAUDE report 11626833 ↗
• MalfunctionSep 1, 2020Material Frayed; Material Frayed

  WHILE ATTEMPTING TO MANEUVER THE CATHETER IN THE CORONARY SINUS, IT DID NOT DEFLECT PROPERLY. WHEN THE CATHETER WAS REMOVED, A FRACTURE WAS NOTED AND THE INNER WIRES WERE EXPOSED. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10479547 ↗
• InjuryApr 5, 2019Difficult to Remove; Difficult to Remove

  DURING A RIGHT VENTRICULAR OUTFLOW TRACT PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING DIFFICULTY ADVANCING THE CATHETER DURING CORONARY SINUS CANNULATION, THE CATHETER APPEARED TO BUCKLE UNDER X-RAY. RESISTANCE WAS NOTED WHEN ATTEMPTING TO REMOVE THE CATHETER. AFTER APPLYING TRACTION FORCE THE CATHETER DISLODGED AND WAS WITHDRAWN. A BEND WAS NOTED AT THE PROXIMAL ELECTRODES WHEN THE DEVICE WAS REMOVED. THE PATIENT REMAINED STABLE FOR THE REMAINDER OF THE PROCEDURE, HOWEVER BECAME HYPOTENSIVE FOLLOWING THE PROCEDURE. AN ELECTROCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION AROUND THE RIGHT VENTRICLE. THE EFFUSION RESOLVED WITHOUT INTERVENTION AND THE PATIENT WAS IN A STABLE CONDITION. IT WAS INDICATED THE EFFUSION MAY HAVE OCCURRED DUE TO THE CATHETER NOT STEERING AS EXPECTED AND BEING ENTANGLED IN THE PATIENTS ANATOMY, LEADING TO WITHDRAWAL DIFFICULTY AND SUBSEQUENT PERICARDIAL EFFUSION.

  Patient problems: Cardiac Perforation

  MAUDE report 8488174 ↗
• InjuryNov 13, 2018Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  DURING THE PROCEDURE, RESISTANCE WAS NOTED DURING DEVICE REMOVAL AND BLEEDING WAS NOTED NEAR THE PATIENT'S GROIN. THE CATHETER APPEARED DAMAGED UNDER FLUOROSCOPY. THE CATHETER WAS UNABLE TO BE MANIPULATED PROPERLY AND COULD NOT BE REMOVED FROM THE PATIENT. RESISTANCE WAS MET NEAR THE GROIN AREA DURING REMOVAL SO THE INTRODUCER AND CATHETER WERE REMOVED TOGETHER. FOLLOWING REMOVAL, THE CATHETER SHAFT WAS TORN AND THE INTERNAL COMPONENTS WERE EXPOSED. THE PATIENT WAS BLEEDING FROM THE REMOVAL SITE AND A D-STAT WAS USED TO STOP THE BLEEDING. THE PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Tissue Damage

  MAUDE report 8064923 ↗
• InjurySep 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 9680001-2018-00138, 3005334138-2018-00323. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. DURING MAPPING OF THE LEFT ATRIUM 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 7877401 ↗