FlexAbility™ A701158Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05415067011503), received between Aug 10, 2018 and Jul 23, 2025 — classified as 1 death, 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJun 24, 2025Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER SHAFT DURING ANALYSIS. THE SHAFT BRAIDING WAS PROTRUDING AT THE POINT OF THE FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22323365 ↗
• InjuryOct 3, 2023Temperature Problem; Temperature Problem

  FOLLOWING A CTI ABLATION PROCEDURE, THE PATIENT WAS DIAGNOSED WITH PERICARDIAL EFFUSION REQUIRING A PERICARDIOCENTESIS AND PLACEMENT OF A DRAIN. DURING THE PROCEDURE WHEN STARTING RF APPLICATION, THE TEMPERATURE WOULD IMMEDIATELY JUMP TO 45°C AND NO POWER COULD BE DELIVERED (<10W). AN EFFUSION WAS NOTED FOLLOWING THE PROCEDURE AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. A DRAIN WAS PLACED, WHICH WAS LEFT IN UNTIL THE DAY AFTER THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 17861603 ↗
• MalfunctionJul 20, 2023Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF MATERIAL SEPARATION NOTED DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17367283 ↗
• MalfunctionJun 8, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17092395 ↗
• MalfunctionMar 11, 2022Improper or Incorrect Procedure or Method; Obstruction of Flow; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Obstruction of Flow; Patient Device Interaction Problem

  DURING THE PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, THE HEPARINIZED SALINE WAS TEMPORARILY STOPPED AND ABOUT TEN MINUTES LATER, THE CATHETER WAS BLOCKED BY A BLOOD CLOT WHEN TRIED TO REFILL IT WITH HEPARINIZED SALINE. WHEN THE CATHETER WAS TAKEN OUT OF THE PATIENT, THE FLUID DID NOT COME OUT THROUGH QUICK FLUSHING WITH INFUSION PUMP AND DIRECT INJECTION WITH SYRINGE. THE CATHETER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13734575 ↗
• MalfunctionJan 12, 2022Failure to Deliver Energy; Insufficient Heating; Patient Device Interaction Problem; Failure to Deliver Energy; Insufficient Heating; Patient Device Interaction Problem

  DURING A LEFT ATRIOVENTRICULAR REENTRANT TACHYCARDIA PROCEDURE, THERE WERE BLOOD STAINS/A SCAB AT THE TIP OF THE CATHETER. IT WAS UNKNOWN IF IT WAS CHAR. IN ADDITION, THE TEMPERATURE AND POWER WOULD NOT INCREASE DURING ABLATION ALTHOUGH THE ABLATION CATHETER WAS ABLE TO ABLATE AT ONE POINT. THE CATHETER WAS REPLACED TO RESOLVE THE ISSUE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13235663 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE, A PERFORATION OCCURRED. AFTER MAPPING THE LATERAL WALL OF THE LV, ABLATION WAS STARTED WHEN THE PATIENT LOST CONSCIOUSNESS BRIEFLY. AN ECG SHOWED QRS BUT THE PATIENT WAS IN ASYSTOLE AND CPR STARTED. AFTER A SHORT PERIOD OF CPR THE PATIENT BLOOD PRESSURE NORMALIZED ALONG WITH THE ECG. AT THIS TIME, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A CARDIAC TAMPONADE, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT IS CURRENTLY IN THE ICU IN STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10779873 ↗
• DeathFeb 6, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  RELATED MANUFACTURER REFERENCE: 2184149-2020-00014, 3008452825-2020-00073. DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A CANCELLATION, TAMPONADE AND SUBSEQUENT DEATH OCCURRED. THE CS CATHETER AND THE HIS CATHETER WERE INTRODUCED VIA THE FEMORAL VEIN INTO THE CORONARY SINUS AND AT THE HIS BUNDLE. DURING INTRODUCTION, EXCESSIVE CATHETER MOVEMENT WAS OBSERVED. A FLEXIBILITY WAS INTRODUCED VIA RETROGRAD ACCESS INTO THE AORTA, AND THE LATMAP AND A GEOMETRY OF THE LVOT WAS COLLECTED. SYSTEM REFERENCE AND RESPIRATION COMPENSATION WERE UTILIZED AND THE UPDATE RESPIRATION WAS OFF. ABLATION WAS STARTED AT THE EARLIEST POINT IN THE LVOT. DUE TO THE CATHETER MOVEMENT, THE CS 5 WAS UTILIZED FOR REFERENCE. FLUORO WAS NOT USED TO LOCATE THE CATHETERS FOLLOWING THE SHIFT. DURING PREPARATION OF CHANGING FROM ARTERIAL ACCESS TO VENOUS ACCESS THE PHYSICIAN NOTICED ABNORMAL STEERING OF THE FLEXIBILITY. FOLLOWING ABLATION IN THE LVOT, THERE WERE STILL PVCS. THE VISUALIZATION OF THE ABLATION CATHETER WAS NOT IN THE CORRECT LOCATION, AND SYSTEM REFERENCE WAS UTILIZED AND A SHIFT OCCURRED. THE CS SHADOW AND CURRENT CS POSITION WERE NOT ALIGNED. THE PHYSICIAN DECIDED TO GO IN RVOT AND A FLEXIBILI

  Patient problems: Cardiac Perforation; Death

  MAUDE report 9677276 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RIGHT VENTRICULAR OUTFLOW TRACT ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED. WHILE MAPPING IN THE RIGHT VENTRICLE OUTFLOW TRACT IN THE ANTEROLATERAL REGION, THE CATHETER WAS ATTEMPTED TO BE MOVED TO THE REGION OF INTEREST BUT IT APPEARED OUTSIDE THE NAVX ANATOMY. THE PATIENT BECAME HYPOTENSIVE AND DIZZY. FLUOROSCOPY AND ECHOCARDIOGRAM WERE PERFORMED, REVEALING A PERFORATION. A PERICARDIOCENTESIS WAS PERFORMED AND MEDICATION WAS GIVEN TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8347744 ↗
• MalfunctionAug 10, 2018Fluid/Blood Leak; Fluid/Blood Leak

  DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE A HANDLE LEAK OCCURRED. WHILE ABLATING A SALINE LEAK WAS OBSERVED FROM THE CATHETER AND A HIGH TEMPERATURE ERROR WAS DISPLAYED ON THE GENERATOR. THE CATHETER WAS REMOVED AND REPLACED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7772905 ↗