FlexAbility™ A701157Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05415067011497), received between Jun 15, 2018 and Nov 25, 2025 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMay 25, 2023Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17003887 ↗
• MalfunctionSep 20, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455632 ↗
• MalfunctionSep 12, 2022Signal Artifact/Noise; High impedance; Signal Artifact/Noise; High impedance

  RELATED MANUFACTURING REF: 3008452825-2022-00596. DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE (PVC), TWO ABLATION CATHETERS SHOWED ABNORMAL IMPEDANCE AND SIGNAL INTERFERENCE WHICH CAUSED A DELAY. WHILE USING THE TACTICATH¿ CONTACT FORCE ABLATION CATHETER, SENSOR ENABLED TO DISCHARGE THE LEFT VENTRICULAR OUTFLOW TRACT FOR 30 SECONDS, IMPEDANCE INCREASED FROM 105 TO OVER 150, ACCOMPANIED BY SIGNAL INTERFERENCE AND THE RADIOFREQUENCY INSTRUMENT AUTOMATICALLY CUT OFF THE DISCHARGE. A FLEXABILITY¿ABLATION CATHETER, UNI-D WAS THEN USED WHICH STARTED NORMALLY, HOWEVER, THE SAME ISSUE OCCURRED APPROXIMATELY 15 MINUTES LATER. THE CATHETER WAS REPLACED AGAIN AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402024 ↗
• MalfunctionAug 23, 2022Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  DURING THE VENTRICULAR TACHYCARDIA PROCEDURE, THE CATHETER BROKE WHEN THE 4 DISTAL ELECTRODES REMAINED IN THE CURVED POSITION (AT 180°) IN THE ARTERY, WHILE BEING INTRODUCED INTO A NON-ABBOTT SHEATH. WHEN THE CATHETER WAS WITHDRAWN, INTERNAL WIRING WAS EXPOSED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15275332 ↗
• MalfunctionAug 22, 2022Signal Artifact/Noise; Fracture; Activation, Positioning or Separation Problem; Signal Artifact/Noise; Fracture; Activation, Positioning or Separation Problem

  DURING THE SUPRAVENTRICULAR TACHYCARDIA PROCEDURE, THE SECOND ELECTRODE AT THE END OF THE CATHETER TIP WAS BROKEN DURING THE SHAPING PROCESS. THE CATHETER WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265054 ↗
• MalfunctionAug 9, 2022Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE REVEALED A FRACTURE IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15191411 ↗
• MalfunctionAug 5, 2022Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURED DEVICE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15178142 ↗
• MalfunctionFeb 14, 2022Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURED CATHETER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525186 ↗
• MalfunctionNov 23, 2021Electrical Shorting; Electrical Shorting

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A SHORT CIRCUIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12861603 ↗
• MalfunctionAug 10, 2021Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT NOTED DURING ANALYSIS REVEALED A FRACTURE IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300020 ↗
• MalfunctionAug 9, 2021Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  DURING THE PROCEDURE, THE CATHETER BECAME LODGED IN THE FEMORAL VEIN AND WAS NOTED TO BE BENT NEAR THE DISTAL END. THE CATHETER WAS CUT SO THE SHORT SHEATH COULD BE REMOVED AND THEN A LONG SHEATH WAS USED TO REMOVE THE CATHETER. THE CATHETER WAS THEN REPLACED AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12293323 ↗
• MalfunctionFeb 25, 2021Fracture; Fracture

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A FRACTURED TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11380282 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A WOLFF-PARKINSON-WHITE ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED. DURING RF ABLATION, A STEAM POP WAS HEARD. THERE WAS NO TEMPERATURE OR IMPEDANCE RISE DURING RF ABLATION. AN ECHOCARDIOGRAM WAS PERFORMED AND A SMALL PERFORATION WAS NOTED. THE LOCATION OF THE PERFORATION IS UNKNOWN, HOWEVER THE PHYSICIAN WAS ABLATING NEAR THE MITRAL ANNULUS AT THE TIME OF THE STEAM POP. THE PATIENT HAD NO SYMPTOMS AND THE PERFORATION REQUIRED NO INTERVENTION. THE PATIENT WAS KEPT OVERNIGHT WITHOUT ANY COMPLICATIONS AND DISCHARGED. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9857065 ↗
• InjurySep 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED. FOLLOWING GEOMETRY COLLECTION, THE ABLATION CATHETER APPEARED OUTSIDE OF THE GEOMETRY DURING FUSION. THE TWO REMAINING CATHETERS APPEARED WITHIN THEIR ANATOMICAL LOCATIONS. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 7918817 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. THE PATIENT BECAME HYPOTENSIVE, AND AN ECHOCARDIOGRAM REVEALED AN EFFUSION ON THE ROOFLINE, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. IT WAS INDICATED THE PERFORATION OCCURRED DUE TO HIGH FORCE ON THE ROOFLINE. THE SINUS RHYTHM WAS REVERTED BY CARDIOVERSION AND THE PROCEDURE WAS STOPPED. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE DURING THE PROCEDURE.

  Patient problems: Cardiac Perforation

  MAUDE report 7641123 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 2030404-2018-00043, 3008452825-2018-00180, 3005334138-2018-00160, 3008452825-2018-00181, 3005334138-2018-00161. DURING A PULMONARY VEIN ISOLATION PROCEDURE. A CARDIAC PERFORATION OCCURRED IN THE SUPERIOR SEPTAL LEFT ATRIUM. DURING GEOMETRY COLLECTION, THE LOWER RIGHT BRANCHES OF THE PULMONARY VEIN WERE DIFFICULT TO ENGAGE DUE A COMMON RIGHT PULMONARY OSTIUM. AFTER GEOMETRY WAS COLLECTED, AN ABLATION LINE ENCIRCLING THE RIGHT VEIN WAS ATTEMPTED AND THE PATIENT BECAME HYPOTENSIVE. AN ULTRASOUND REVEALED AN EFFUSION IN THE SUPERIOR SEPTAL LEFT ATRIUM FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. FURTHER ABLATION WAS ABORTED. THERE WERE NO PERFORMANCE ISSUES WITH THE ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 7604672 ↗