Inquiry™ IBI-81530Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05414734304771), received between Jul 24, 2019 and Jun 29, 2022 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionJun 29, 2022Material Twisted/Bent; Material Twisted/Bent

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, A KINK WAS NOTED AROUND ELECTRODE 5/6. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS CANCELLED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14852465 ↗
• InjuryJul 29, 2021Difficult to Remove; Difficult to Remove

  FOLLOWING A SUCCESSFUL PREMATURE VENTRICULAR CONTRACTIONS (PVC) PROCEDURE, WORSENING OF A BASELINE PERICARDIAL EFFUSION OCCURRED. AT THE END OF THE PROCEDURE, AS THE CATHETER WAS REMOVED, THERE WAS DIFFICULTY, AND A KINK AND POSSIBLE FRACTURE WAS NOTED PROXIMAL TO THE LAST ELECTRODE. FOLLOWING THE PROCEDURE, WHILE MONITORING THE BASELINE EFFUSION VIA ICE AND ECHO, IT WAS NOTED TO HAVE WORSENED AND A PERICARDIOCENTESIS WAS PERFORMED AND 800 ML/FLUID WAS REMOVED. THE PHYSICIAN ALLEGES THE WORSENING OF THE EFFUSION WAS LIKELY DUE TO DIFFICULTY REMOVING THE CATHETER. THE PATIENT IS CURRENTLY IN STABLE CONDITION AND HAS BEEN DISCHARGED.

  Patient problems: Cardiac Perforation

  MAUDE report 12245099 ↗
• 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, 3008452825-2019-00359. 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 FLEXABILITY 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 OR. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8821473 ↗