FlexAbilityRecalls & reported problems across all models

We found 13 models of FlexAbility by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 220 adverse event reports in the FDA's MAUDE database, received between Jun 15, 2018 and Sep 25, 2026 — classified as 17 deaths, 139 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Fracture” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FlexAbility problems

FlexAbility models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FlexAbility™ A-FASE-DF

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  6 deaths65 reports
• FlexAbility™ A-FASE-D

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  4 deaths33 reports
• FlexAbility™ A701125

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  2 deaths29 reports
• FlexAbility™ A-FASE-FJ

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 death29 reports
• FlexAbility™ A-FASE-F

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  20 reports
• FlexAbility™ A701157

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  18 reports
• FlexAbility™ A701158

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 death12 reports
• FlexAbility™ A701128

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  2 deaths5 reports
• FlexAbility™ A-FASE-DD

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  3 reports
• FlexAbility™ A701124

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  2 reports
• FlexAbility™ A-FASE-JJ

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  2 reports
• FlexAbility™ A701159

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 report
• FlexAbility™ A-FASE-FF

  catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
  1 death1 report

Recent FlexAbility adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Perforation

  MAUDE report 50902644 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE IN THE LEFT ATRIUM, THE ROOF WAS PUNCTURED RESULTING IN A PERICARDIOCENTESIS BEING PERFORMED. AN ECHOCARDIOGRAM WAS PERFORMED AND CONFIRMED THE PUNCTURE. THE BLOOD WAS DRAINED FROM THE PERICARDIAL SAC. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. THE PHYSICIAN ALLEGES THE ABLATION CATHETER AS THE CAUSE FOR THE CARDIAC PERFORATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 24319176 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN AVNRT PROCEDURE, THE PATIENT EXPERIENCED AV BLOCK WHILE TARGETING THE SLOW PATHWAY. NO INTERVENTION WAS PERFORMED TO TREAT THE ARRHYTHMIA. THE AV BLOCK APPEARED 15MM FROM THE BUNDLE OF HIS IN A ZONE WITH ALMOST NO A SIGNAL. AT THE END OF THE PROCEDURE, THE ARRHYTHMIA WAS STILL PRESENT. THERE WERE NO PERFORMANCE ISSUES WITH THE FLEXABILITY CATHETER.

  Patient problems: Arrhythmia

  MAUDE report 24026446 ↗
• MalfunctionJan 8, 2026Obstruction of Flow

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, THERE WAS A FLOW ISSUE WITH THE CATHETER RESULTING IN A DELAY. THE SYSTEM ISSUED A WARNING AND STOPPED ABLATION WHEN THE FLOW RATE INCREASED FROM 2ML/MIN TO 17ML/MIN. CONNECTIONS WERE CHECKED, THE PUMP AND CABLES WERE REPLACED, AND THE CATHETER WAS FLUSHED, BUT THE ISSUE REMAINED. THE CATHETER WAS THEN REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005616 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE END OF A WPW PROCEDURE IN THE RA WITH THE ENSITE X SYSTEM AND THE FLEXABILITY ABLATION CATHETER, THE PATIENT EXPERIENCED AN ST ELEVATION. A CORONARY ANGIOGRAPHY WAS PERFORMED AND A STENT WAS IMPLANTED DUE TO AN OCCLUSION OF THE POSTEROLATERAL RCA. THE PHYSICIAN IS UNSURE OF THE EXACT CAUSE OF THE ST ELEVATION, POTENTIALLY THERMAL TRAUMA OF THE RF ENERGY NEAR THE CORONARY SINUS. THE PHYSICIAN STATED THERE WAS NO MALFUNCTION OF THE CATHETER. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 23796308 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR EXTRASYSTOLE PROCEDURE, AFTER PERFORMING SOME ABLATIONS, AN INCREASE IN HEART RATE WAS NOTED. A FLUOROSCOPY WAS DONE WHICH REVEALED A PERICARDIAL EFFUSION, A PERFORATION WAS LOCATED IN THE RIGHT VENTRICLE OUTLET. A PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT STABILIZED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE, PROGRESSING WELL, WAS EXTUBATED, AND LEFT THE ROOM AWAKE. NO COMPLICATIONS IN THE POST-OPERATIVE PERIOD. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 23742961 ↗
• InjuryNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION (PVC) PROCEDURE, A STEAM POP OCCURRED FOLLOWED BY A CARDIAC TAMPONADE WHICH REQUIRED A PERICARDIOCENTESIS. DURING THE FOURTH ABLATION APPLICATION, A POP WAS HEARD. A DECREASE IN BLOOD PRESSURE WAS OBSERVED AND FLUOROSCOPY REVEALED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PVC FOCUS WAS AT THE ANTERIOR PORTION OF THE RIGHT VENTRICULAR OUTFLOW TRACT, ACCORDING TO THE PHYSICIAN, THIS ANATOMICAL LOCATION HAS A SLIGHTLY THINNER WALL COMPARED TO OTHER REGIONS OF THE RIGHT VENTRICLE.

  Patient problems: Cardiac Perforation

  MAUDE report 23646843 ↗
• 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 ↗
• MalfunctionAug 26, 2025Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  DURING AN ACCESSORY PATHWAY PROCEDURE, THE CATHETER FRACTURED WHICH REQUIRED REPLACEMENT. AFTER ACCESSING THE LEFT VENTRICLE TO MAP THE MITRAL ANNULUS, THE CATHETER COULD NOT BE MANIPULATED. THE CATHETER WAS RETRACTED FROM THE PATIENT AND IT WAS NOTED THAT THE TIP OF THE CATHETER WAS FRACTURED. THE CATHETER WAS REPLACED. AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22900438 ↗
• MalfunctionAug 21, 2025Communication or Transmission Problem; Communication or Transmission Problem

  THIS REPORT IS TO ADVISE OF A FRACTURE THAT WAS NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860490 ↗
• DeathJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE, A TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS AND SURGERY. WHEN THE REGION OF INTEREST WAS ASSESSED, A FEW APPLICATIONS WERE DONE AT 40 WATTS AND THE PATIENT EXPERIENCED CARDIOGENIC SHOCK. FLUOROSCOPY AND ECHOCARDIOGRAM WERE PERFORMED WHICH REVEALED A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED FOLLOWED BY SURGERY TO RESOLVE THE BLEEDING. THE PATIENT IS IN INTENSIVE CARE AND ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 22663883 ↗
• MalfunctionJul 23, 2025Signal Artifact/Noise; Impedance Problem; Signal Artifact/Noise; Impedance Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, SIGNAL ISSUES RESULTED IN A PROCEDURAL DELAY. AFTER CONNECTING THE ABLATION CATHETER TO THE GENERATOR, INTERFERENCE WAS NOTED AT THE CATHETER TIP. THE FILTER AND OTHER SETTINGS WERE CHECKED BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED BUT THE SAME ISSUE OCCURRED. AFTER INSERTION INTO THE ATRIUM, ABNORMAL IMPEDANCE WAS NOTED. THE SECOND CATHETER WAS REPLACED WHICH RESOLVED THE ISSUE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580370 ↗
• MalfunctionJul 23, 2025Signal Artifact/Noise; Signal Artifact/Noise

  DEVICE RECEIVED FOR EVALUATION. THIS REPORT INCLUDES AN UPDATED ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579954 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION AND ATRIAL FLUTTER ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED WHICH REQUIRED A PERICARDIOCENTESIS TO STABILIZE THE PATIENT. WHILE PERFORMING ABLATION, A DROP IN BLOOD PRESSURE WAS OBSERVED AND A FLUOROSCOPY WAS DONE WHICH REVEALED A TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. NO FAILURE OR DEFECT WAS DETECTED IN ANY ABBOTT DEVICE; THE INCIDENT WAS DUE TO A MANEUVER PERFORMED BY THE PHYSICIAN DURING THE PASSAGE OF THE CATHETER.

  Patient problems: Cardiac Perforation

  MAUDE report 22373683 ↗

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