FlexAbility™ A-FASE-JJRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05415067020093), received between Sep 9, 2025 and Sep 18, 2025 — classified as 2 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS PUBLISHED IN THE JOURNAL SCIENTIFIC REPORTS IN AN ARTICLE TITLED, "EARLY ABLATION LEADS TO BETTER OUTCOME IN PATIENTS < 55 YEARS WITH PERSISTENT ATRIAL FIBRILLATION" ERHARD, NICO, VOL. 14, NO. 1, 25 OCT. 2024, HTTPS://DOI.ORG/10.1038/S41598-024-76098-2. THIS RETROSPECTIVE SINGLE CENTER STUDY INCLUDED A COHORT OF 101 PATIENTS = 55 YEARS (AT TIME OF ABLATION) WHO WERE DIAGNOSED WITH PERSISTENT AF AND UNDERWENT FIRST-TIME RADIOFREQUENCY CATHETER ABLATION (RFCA) AT OUR CENTER BETWEEN JANUARY 2017 AND DECEMBER 2020. PERSISTENT AF WAS DEFINED ACCORDING TO CURRENT GUIDELINES4. PATIENTS WITH PREVIOUS LEFT ATRIAL CATHETER ABLATIONS, OTHER ATRIAL ARRYTHMIAS, WITH CONGENITAL HEART DEFECT (EXCLUDING PFO AND MINOR ASD) WERE EXCLUDED FROM THE STUDY. PATIENTS WERE DIVIDED IN THOSE WHO UNDERWENT ABLATION WITHIN 12 MONTHS AFTER AF DIAGNOSIS OR > 12 MONTHS AFTER AF DIAGNOSIS. PRIMARY OUTCOME WAS ABLATION SUCCESS, DEFINED AS THE ABSENCE OF AF RECURRENCE. PROCEDURE-RELATED COMPLICATIONS OCCURRING WITHIN 30 DAYS OF ABLATION WERE ALSO ASSESSED. ETHICAL APPROVAL WAS GRANTED FROM THE INSTITUTIONAL REVIEW BOARD (ETHICAL COMMITTEE OF THE TECHNICAL UNIVERSITY OF MUNICH, (APPROVAL #2020 - 34

  Patient problems: Fistula; Stroke/CVA

  MAUDE report 23086493 ↗
• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS PUBLISHED IN THE JOURNAL OF CLINICAL MEDICINE IN AN ARTICLE TITLED, "EFFICACY OF CATHETER ABLATION USING THE ELECTRO ANATOMICAL SYSTEM WITHOUT THE USE OF FLUOROSCOPY IN PATIENTS WITH VENTRICULAR EXTRA SYSTOLIC BEATS" RODKIEWICZ, DARIUSZ, 24 JULY 2023, 12, 4851. HTTPS://DOI.ORG/10.3390/JCM12144851. THE STUDY INCLUDED 109 PATIENTS WITH SYMPTOMATIC VEBS, WHO WERE QUALIFIED FOR THE ABLATION PROCEDURE BASED ON 24 H ECG HOLTER (MORE THAN 10.000 VEBS PER DAY). THE PURPOSE OF THE STUDY WAS TO PERFORM EVERY PROCEDURE FOLLOWING THE ALARA RULE OF USING FLUOROSCOPY (AS LOW AS REASONABLY ACHIEVABLE). ONLY WHEN THERE WAS A NECESSITY ARISING FROM THE FACTORS DESCRIBED BELOW, FLUOROSCOPY WAS USED. COMPLETELY FLUOROLESS CA OF VEBS GUIDED BY THE EAM SYSTEM WAS PERFORMED IN 94 (86%) CONSECUTIVE PATIENTS WITH VEBS, WHEREAS CONVENTIONAL FLUOROSCOPY-GUIDED CA WAS PERFORMED IN 15 (13,8%) SUCH PATIENTS. PROCEDURES WERE PERFORMED BETWEEN JANUARY 2020 AND SEPTEMBER 2022. PARTICIPANTS SIGNED WRITTEN INFORMED CONSENT FORMS. DEMOGRAPHIC AND CLINICAL DATA WERE OBTAINED FROM THE MEDICAL RECORDS. THERE WAS 1 OCCURRENCE OF TAMPONADE AFTER RF REQUIRING A PERICARDIOCENTESIS.

  Patient problems: Cardiac Perforation

  MAUDE report 23006599 ↗