FlexAbility™ A701125Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05415067011114), received between Jun 27, 2018 and Sep 25, 2026 — classified as 2 deaths, 15 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 25 most recent of 29 reports, 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 ↗
• 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 ↗
• 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 THE CATHETER WAS RETRACTED FROM THE PATIENT AND IT WAS NOTED THAT THE TIP OF THE CATHETER WAS FRACTURED.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 ↗
• 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 ↗
• MalfunctionOct 15, 2024Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER SHAFT DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20448185 ↗
• DeathJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE MONDAY FOLLOWING A SUCCESSFUL VENTRICULAR TACHYCARDIA PROCEDURE THAT TOOK PLACE ON (B)(6)2024, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNCONFIRMED BUT SUSPECTED TO BE DUE TO POSSIBLE HEMORRHAGIC SHOCK. THERE WERE NO ALLEGED ISSUES WITH ANY ABBOTT DEVICES. THERE WAS NO PERICARDIAL LEAKAGE. IT IS ALLEGED TO HAVE BEEN A RETROPERITONEUM BLEED DUE TO FEMORAL ARTERY HANDLING THAT APPEARED CLOGGED DURING THE PROCEDURE, BUT IT IS UNCONFIRMED.

  Patient problems: Hypovolemic Shock

  MAUDE report 19698499 ↗
• InjuryFeb 13, 2024Improper or Incorrect Procedure or Method; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Patient Device Interaction Problem

  THIS REPORT INCLUDES AN UPDATED EVENT DESCRIPTION. DURING A LEFT VENTRICLE ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHICH REQUIRED CARDIAC SURGERY TO REPAIR AND STABILIZE THE PATIENT. THE PATIENT ENTERED THE ROOM, WAS MONITORED, ANESTHETIZED AND A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) PROBE WAS PASSED. THREE FEMORAL VENOUS ACCESSES AND ONE ARTERIAL ACCESS WERE PERFORMED. THE RESIDENT PHYSICIAN INTRODUCED THE RETROAORTIC FLEXABILITY ABLATION CATHETER AND ACCESSED THE LEFT VENTRICLE. WHEN THE CHIEF PHYSICIAN ARRIVED, HE REMOVED THE FLEXABILITY ABLATION CATHETER AND INSERTED THE 8MM TIP ABLATION CATHETER. TRANSSEPTAL PUNCTURES WERE PERFORMED AND ACCESS TO THE LEFT ATRIUM WERE DONE WITH A SWARTZ SHEATH AND AN AGILIS SHEATH. USING TEE AND THE ENSITE MAPPING SYSTEM, HE CONSTRUCTED THE ANATOMY OF THE LEFT VENTRICLE AND PERFORMED SOME RADIOFREQUENCY APPLICATIONS AT SOME POINTS USING 70W OR 60W OF POWER. THE ANATOMY OF THE LEFT ATRIUM WAS CONSTRUCTED WITH THE CIRCULAR CATHETER. AFTER SEPTAL ABLATION OF THE LEFT VENTRICLE, THE PATIENT WAS CARDIOVERTED TO TAKE HER OUT OF THE ATRIAL FIBRILLATION RHYTHM. THE PHYSICIAN THEN PLACED THE FLEXABILITY CATHETER IN THE AGILIS SHEAT

  Patient problems: Cardiac Perforation; Thrombosis/Thrombus

  MAUDE report 18698903 ↗
• DeathAug 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A LEFT VENTRICULAR END SYSTOLIC VOLUME PROCEDURE, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, AND EXPIRED. AFTER MAPPING THE LEFT VENTRICLE AND RADIOFREQUENCY APPLICATIONS WITHOUT INTERRUPTION OF THE ARRHYTHMIA, A NEW MAP WAS COMPLETED. DURING THIS HEMODYNAMIC INSTABILITY WAS OBSERVED INCLUDING BRADYCARDIA, HYPERTENSION, AND SWEATING. THE HEMODYNAMICISTS WAS CALLED IN, CARDIAC CATHETERIZATION WAS PERFORMED, ANGIOPLASTY WITH IMPLANTATION OF TWO STENTS, CARDIAC COMPRESSION WAS STARTED, AND SHOCK WAS DELIVERED, WITHOUT SUCCESS. THERE WERE NO ALLEGED PERFORMANCE ISSUES WITH ANY ABBOTT PRODUCTS AND IT IS UNKNOWN WHAT CAUSED THE PATIENT TO BECOME UNSTABLE.

  Patient problems: Arrhythmia

  MAUDE report 17538234 ↗
• MalfunctionJun 6, 2023Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17072085 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN EPICARDIAL VENTRICULAR TACHYCARDIA (VT) PROCEDURE, A CARDIAC TAMPONADE OCCURRED WITH A PERICARDIOCENTESIS, AND SUBSEQUENT THORACOTOMY PERFORMED. THE CATHETER WAS IN THE EPICARDIUM FOR MAPPING AND BLEEDING WAS NOTED IN THE CAVITY. A FLUOROSCOPY REVEALED A TAMPONADE IN THE ANTERIOR WALL OF THE RIGHT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED WHICH DID NOT RESOLVE THE BLEEDING. THE PATIENT WAS THEN TRANSFERRED TO THE SURGICAL CENTER FOR A THORACOTOMY, WHICH WAS SUCCESSFULLY PERFORMED, AND THE PATIENT STABILIZED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 17002668 ↗
• MalfunctionJan 26, 2023Fracture; Fracture

  THIS REPORT IS TO ADVISE OF A FRACTURE FOUND IN THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251392 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, THE PATIENT SUFFERED CARDIAC ARREST DUE TO ARRHYTHMIA REQUIRING RESUSCITATION. RF ENERGY WAS DELIVERED IN THE SITE OF THE EARLIEST SIGNAL, IDENTIFIED AS MITRAL AORTIC REGION. THE FLEXABILITY CATHETER WAS USED WITH THE FOLLOWING ABLATION PARAMETERS: 30W, 43ºC, 150 OHMS, 13ML/MIN. AFTER ABLATION, THE PHYSICIAN WAITED 5 MINUTES TO SEE IF ANOTHER PVC WOULD OCCUR BEFORE STARTING FURTHER EP STUDY PROTOCOLS (MEASURE HV INTERVAL ~53MS, WENCKEBACH POINT). AFTER THIS, ISOPROTERENOL WAS USED TO INCREASE PATIENT'S HEART FREQUENCY AND TO TEST WHETHER THE ABLATION WAS SUCCESSFUL. NO PVCS WERE OBSERVED, BUT WHEN THE EFFECT OF ISOPROTERENOL WAS DECREASING, VENTRICULAR FIBRILLATION STARTED AND THE PATIENT HAD NO PALPABLE PULSE. CPR WAS PERFORMED AND SEVERAL SHOCKS WERE DELIVERED WITH AN EXTERNAL DEFIBRILLATOR. SINUS RHYTHM WAS REESTABLISHED AFTER 30 MINUTES, THE PATIENT WAS STABILIZED AND WENT TO ICU FOR RECOVERY. LATER THAT DAY THE PATIENT HAD A SPASM OF THE ANTERIOR DESCENDENT CORONARY ARTERY, WHICH CAUSED VENTRICULAR FIBRILLATION. ON THE SAME DAY, AN ANGIOPLASTY WAS PERFORMED.

  Patient problems: Arrhythmia; Cardiac Arrest

  MAUDE report 15811986 ↗
• InjuryOct 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A TYPICAL FLUTTER PROCEDURE, A STEAM POP OCCURRED WITH RESULTING THROMBUS. WHILE ABLATING THE CTI (40W) APPROXIMATELY HALFWAY DOWN THE LINE, A STEAM POP WAS HEARD. HEMODYNAMIC MONITORING WAS STABLE THROUGHOUT THE PROCEDURE WITH NO OBVIOUS SIGNS OF ADVERSE EVENTS. THE CTI LINE CONTINUED WITH POWER REDUCED TO 30W AND THEN DOWN TO 25W AT THE IVC END. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT NO ADVERSE EVENTS AND THE PATIENT LEFT THE LAB. THE PATIENT WAS ADMITTED WITHIN A WEEK WITH CHEST PAIN AND A TROPONIN RISE. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED THROMBUS IN THE RIGHT CORONARY ARTERY. THE THROMBUS WAS REMOVED, A STENT WAS PLACED, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15626597 ↗
• MalfunctionSep 19, 2022High impedance; High impedance

  RELATED MANUFACTURING REF: 3008452825-2022-00602. DURING A SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, HIGH IMPEDANCE WAS NOTED WHICH CAUSED A DELAY IN THE PROCEDURE. THE CATHETER DISPLAYED A HIGH IMPEDANCE VALUE. THE CATHETER WAS EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. A THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446380 ↗
• InjuryMar 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING RADIO FREQUENCY APPLICATION, CHANGES IN THE PATIENTS HEART RATE WERE NOTED AND THE PATIENT BECAME HYPOTENSIVE. A PERICARDIAL EFFUSION WAS DIAGNOSED IN THE LEFT VENTRICLE. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT AND THE PATIENT IS UNDER OBSERVATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 13872796 ↗
• MalfunctionDec 5, 2021Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURE RESULTING IN EXPOSED COMPONENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12931224 ↗
• MalfunctionNov 15, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  RELATED MANUFACTURER REF: (B)(4). DURING A PREMATURE VENTRICULAR CONTRACTIONS ABLATION PROCEDURE, A PROLONGED PROCEDURE OCCURRED DUE TO A DEFLECTION ISSUE WITH THE CATHETER, THE TIP OF THE INTRODUCER BEING BENT, AND HAVING TO EXCHANGE BOTH OF THE DEVICES. THE DEVICES WERE EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813605 ↗
• MalfunctionOct 19, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS REPORT IS TO ADVISE OF AN EVENT NOTED DURING ANALYSIS WHICH REVEALED A FRACTURED TIP OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657112 ↗
• MalfunctionApr 7, 2021Insufficient Heating; Insufficient Heating

  DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO HEAT TO TEMPERATURE. THE PROCEDURE WAS CANCELLED DUE TO THIS ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632070 ↗
• MalfunctionMar 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION ABLATION PROCEDURE, THE TIP OF THE CATHETER WAS BLOCKED WITH BLOOD AND THE IRRIGATION OF SALINE WAS OBSTRUCTED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11530985 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ANGIOPLASTY PROCEDURE, WHILE MAPPING, THE ELECTROCARDIOGRAM BEGAN TO SHOW ST SEGMENT ELEVATION AND LOW ARTERY PRESSURE. AT THIS TIME MAPPING WAS STOPPED AND MEDICATION WAS ADMINISTERED TO HELP REGULATE BLOOD PRESSURE. AN ULTRASOUND WAS PERFORMED REVEALING THE CORONARY ARTERY WAS NOT FUNCTIONING PROPERLY AND THE PATIENT WAS TRANSFERRED TO THE HEMODYNAMICS SECTOR FOR EVALUATION. WHILE WAITING FOR TRANSPORT, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION AND A CARDIAC MASSAGE WAS STARTED AND A SHOCK WITH A DEFIBRILLATOR WAS PERFORMED TO STABILIZE THE PATIENT. THE PATIENT WAS TRANSFERRED TO HEMODYNAMICS AND A DISSECTION OF THE RIGHT CORONARY ARTERY WAS OBSERVED WHICH WAS THOUGHT TO BE SPONTANEOUS. A STENT WAS PLACED IN THE RIGHT CORONARY TO STABILIZE THE PATIENT AND THE PATIENT WAS DISCHARGED TWO DAYS FOLLOWING THE PROCEDURE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Vascular Dissection

  MAUDE report 11332052 ↗
• MalfunctionFeb 1, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION, A DELAY OCCURRED. THE CONNECTION BETWEEN THE CATHETER AND THE AMPERE GENERATOR WAS DISCONNECTED WHEN RF DELIVERY WAS BEING PERFORMED. AN ERROR MESSAGE WAS DISPLAYED ON THE REMOTE STATING THE CONNECTION TO THE CATHETER WAS DISCONNECTED. AFTER A FEW SECONDS, THE CONNECTION WAS RE-ESTABLISHED AND RF DELIVERY WAS ABLE TO BE PERFORMED; HOWEVER, THE SAME ISSUE OCCURRED AGAIN AFTER A FEW TIMES. THE CONNECTING CABLE WAS EXCHANGED WITH NO RESOLUTION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11262322 ↗
• MalfunctionDec 23, 2020Overheating of Device; Overheating of Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A HIGH ABLATION TEMPERATURE NOTED WHILE TESTING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11064511 ↗
• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REPORT NUMBERS: 2182269-2020-00087, 3005334138-2020-00466, 3008452825-2020-00521, 2030404-2020-00083. AT THE END OF A PVC ABLATION PROCEDURE, DURING RF OF THE LAST LESION, A PERICARDIAL EFFUSION OCCURRED. THE DUO CATHETER WAS PLACED IN THE CORONARY SINUS AND THE FLEXIBILITY WAS USED FOR ABLATION OF THE PVC'S IN THE RIGHT VENTRICLE. REINFORCEMENT OF THE LESIONS IN THE RIGHT VENTRICLE WERE VERIFIED TO CONFIRM ELIMINATION OF THE ARRHYTHMIA. HOWEVER, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10669297 ↗
• InjuryMar 5, 2020Overheating of Device; Communication or Transmission Problem; Connection Problem; Excessive Heating; Overheating of Device; Communication or Transmission Problem; Connection Problem; Excessive Heating

  RELATED MANUFACTURER REFERENCE: 2184149-2020-00032. DURING THE PROCEDURE, THE TEMPERATURE OF THE CATHETER WAS HIGHER THAN EXPECTED (APPROXIMATELY 90ºC). THE CATHETER ALSO HAD CONNECTION ISSUES TO THE AMPERE GENERATOR. THE PROCEDURE WAS CANCELLED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9795249 ↗