FlexAbility™ A701128Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05415067011145), received between Jan 25, 2019 and Jan 28, 2021 — classified as 2 deaths, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A RIGHT AF PROCEDURE, BLOOD COAGULATED IN THE HOLE OF THE TIP OF THE CATHETER AND THE IRRIGATION WAS BLOCKED. THE CATHETER WAS INTRODUCED INTO THE PATIENT, AND AFTER 5 MINUTES IT WAS NOTED THAT THE PHYSICIAN FORGOT TO CONNECT THE TUBING TO THE CATHETER. THE DEVICE WAS REMOVED, AND IRRIGATION WAS ATTEMPTED BUT THE PUMP ALARMED STATING THAT THE PRESSION WAS HIGH DUE TO COAGULATED BLOOD THAT WAS ON THE IRRIGATION TIP. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11244666 ↗
• DeathAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. A TRANSSEPTAL PUNCTURE WAS PERFORMED USING GUIDED INTRACARDIAC ECHOCARDIOGRAM AND A TRANSESOPHAGEAL ECHOCARDIOGRAM DUE TO ANATOMICAL CHANGES IN THE INTERATRIAL SEPTUM (HYPERTROPHY). DIFFICULTY WAS NOTED MANEUVERING THROUGH THE LEFT ATRIUM TO THE LEFT VENTRICULAR WITH THE FLEXABILITY CATHETER AND THE MD OPTED TO USE A RETROGRADE APPROACH. DURING THIS APPROACH, A CARDIAC TAMPONADE WAS DIAGNOSED BY ECHOCARDIOGRAM REQUIRING AT THORACOTOMY FOR DRAINAGE. THE PATIENT EXPERIENCED SEVERE HEMORRHAGIC SHOCK, SEVERE SYSTEMIC DYSFUNCTION REFRACTORY TO MEASURES OF BLOOD PRODUCTS, VASOACTIVE DRUGS AND INTRA-AORTIC BALLOON PUMP RESULTING IN DEATH. IT WAS UNKNOWN WHEN THE PERFORATION OCCURRED, OR WHICH DEVICE CAUSED THE TAMPONADE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Death

  MAUDE report 10430816 ↗
• MalfunctionJun 10, 2019Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN INCIDENTAL FINDING OF CATHETER SHAFT DAMAGE, EXPOSING INTERNAL COMPONENTS OBSERVED DURING ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682853 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 2182269-2019-00064, 3008452825-2019-00243, 2182269-2019-00065, 2182269-2019-00066. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC EFFUSION OCCURRED. DURING ABLATION OF THE CAVOTRICUSPID ISTHMUS (CTI), A POTENTIAL STEAM POP OCCURRED, HOWEVER IT COULD NOT BE CONFIRMED. THE PROCEDURE WAS ABLE TO BE COMPLETED. FOLLOWING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE. INTRA-CARDIAC ECHOCARDIOGRAPHY(ICE) CONFIRMED AN EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8631871 ↗
• DeathJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00022, 3005334138-2019-00028, 3005334138-2019-00029, 3008452825-2019-00023, 2182269-2019-00007. FOLLOWING AN ATRIAL FIBRILLATION PROCEDURE, THE PATIENT EXPIRED. DURING THE PROCEDURE, THE SEPTUM FELT HARD (NON-ELASTIC), FIBROTIC AND RESISTANT DUE TO A PREVIOUS PROCEDURE. DURING POST PROCEDURE HOSPITALIZATION, A PERICARDIAL EFFUSION WAS DISCOVERED WHICH EVOLVED INTO CARDIAC ARREST DURING THE NIGHT. REANIMATION WITH CARDIAC MASSAGE WAS PERFORMED, HOWEVER THE EFFECT OF THE CARDIAC ARREST LED TO CEREBRAL DEATH EIGHT DAYS POST PROCEDURE AND THE PATIENT EXPIRED ON (B)(6) 2019. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Death

  MAUDE report 8276884 ↗