FlexAbility™ A-FASE-FRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05415067020048), received between Dec 7, 2018 and Mar 18, 2025 — classified as 16 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A STEAM POP AND PERFORATION OCCURRED IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) REQUIRING A PERICARDIOCENTESIS AND SURGERY. THE PATIENT WAS HAVING VENTRICULAR TACHYCARDIAS (VT) THAT WERE MAPPED TO THE RVOT. THE ABLATION CATHETER WAS MOVED TO THE EARLIEST SIGNAL AND STARTED ABLATION. AFTER SEVERAL ABLATIONS, THE PHYSICIAN HEARD AN AUDIBLE POP THE PHYSICIAN CAME OFF ABLATION AND WAITED. SHORTLY AFTER HE CAME OFF ABLATION, IT WAS NOTED THAT THE PATIENTS PRESSURE WAS DROPPING. ICE WAS DONE WHICH REVEALED A PERFORATION. A PERICARDIOCENTESIS WAS PERFORMED, AND THE PATIENT WAS TAKEN TO SURGERY WHERE THE STEAM POP WAS SUTURED CLOSED. THE PATIENT IS STABLE AND RECOVERING.

  Patient problems: Cardiac Perforation

  MAUDE report 21631681 ↗
• MalfunctionJul 26, 2024Material Deformation; Material Deformation

  THIS REPORT IS TO ADVISE OF A DISPLACED ELECTRODE EXPOSING INTERNAL WIRING FOUND ON THE CATHETER DURING ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840943 ↗
• MalfunctionApr 17, 2024Overheating of Device; Overheating of Device

  DURING THE ATRIAL TACHYCARDIA PROCEDURE, TEMPERATURE ISSUES WITH THE CATHETER RESULTED IN A PROCEDURAL DELAY. THE CATHETER WAS CONNECTED TO THE GENERATOR, A TEMPERATURE OF 69 DEGREES CELSIUS WAS OBSERVED. THE TAIL LINE AND THE GENERATOR WERE BOTH REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE 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 19127549 ↗
• MalfunctionNov 8, 2023Communication or Transmission Problem; Communication or Transmission Problem

  SALES REP CONFIRMED WITH THE HOSPITAL THAT IT TOOK ABOUT 10 MINUTES FROM FINDING THE PROBLEM TO SOLVING IT; NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091882 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC TAMPONADE WAS NOTED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 16328577 ↗
• InjuryNov 22, 2022Communication or Transmission Problem; Temperature Problem; Communication or Transmission Problem; Temperature Problem

  RELATED MANUFACTURING REF: (B)(4). DURING THE PAROX ATRIAL FIBRILLATION, NATIVE ATRIAL TACHYCARDIA, AND TYPICAL ATRIAL FLUTTER PROCEDURE, THERE WAS A PERICARDIAL EFFUSION, REQUIRING DRAINAGE. THE FOLLOWING ISSUES WITH ENSITE X OCCURRED DURING THE PROCEDURE: WHEN THE PROCEDURE WAS STARTED THE SYSTEM SHOWED THAT THE MAGNET WAS NOT CONNECTED. ALL OF THE CABLES WERE IN PLACE. THE CABLE NEAR THE FIELD FRAME WAS NOT PROPERLY CONNECTED AND ONCE THAT WAS FIXED THE AMPLIFIER STARTED AS NORMAL. THE PRS-A WAS MOVED TWICE TO SET THE METAL BASELINE IN A NORMAL DETECTOR POSITION. IN VOXEL MODE THE METAL BASELINE WAS SET AND THERE WAS A LOT OF VOXEL WHEN MAPPING WAS STARTED WITH THE HD GRID. BUT THE CATHETER WAS IN LOW CONFIDENCE WHICH APPEARED TO BE RELATED TO IRREGULAR RESPIRATION AND BEING INSIDE THE VEINS. RESPIRATION COMPENSATION WAS NOT WORKING AS INTENDED AND THE RESPIRATION REJECTION HAD TO BE TURNED OFF TO COMPLETE ABLATION AND MAPPING. POINT COLLECTION ON THE SHAFT CAUSED FALSE SPACE AND THERE WAS A LOT OF INTERPOLATION BETWEEN THE VEINS. THERE WAS A LOT OF COMPLEX SUBSTRATE. THE LAP MAP PICKED UP A LOT OF WRONG POINTS RELATED TO ARTIFACT, WHICH WAS CAUSED BY TURNING OFF THE ENHANCED NO

  Patient problems: Cardiac Perforation

  MAUDE report 15844936 ↗
• MalfunctionOct 20, 2022Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638591 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A FOCAL VENTRICULAR TACHYCARDIA PROCEDURE, A CARDIAC PERFORATION OCCURRED. THE RIGHT VENTRICULAR OUTFLOW TRACK WAS MAPPED AND IT WAS DECIDED TO MAP THE LEFT SIDE WHEN IT WAS DETERMINED THE TACHYCARDIA WAS COMING FROM THERE. THE PHYSICIAN CROSSED THE PFO WITH A FLEXIBILITY CATHETER. FOLLOWING MAPPING OF THE LEFT VENTRICLE, THE LOCATION OF THE PREMATURE VENTRICULAR CONTRACTION WAS DETERMINED TO BE AT A BASAL SEPTAL LOCATION. FOLLOWING THE FIRST ABLATION, THE PATIENTS BLOOD PRESSURE BEGAN TO DROP. A TRANSTHORACIC ECHO WAS PERFORMED AND IT WAS DETERMINED THAT THERE WAS A PERICARDIAL EFFUSION. AT THIS POINT THE CASE WAS ABANDONED AND A PERICARDIOCENTESIS WAS PERFORMED SUCCESSFULLY. THE PHYSICIAN DID NOT INDICATE ANY PART OF THE SYSTEM OR CATHETERS WERE THE CAUSE OF THE EFFUSION. THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation

  MAUDE report 15476215 ↗
• InjuryJun 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, THE PATIENT WAS NOTED TO BE HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ECHOCARDIOGRAM. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS STABILIZED. THE PROCEDURE WAS STILL ABLE TO BE COMPLETED. THE PATIENT WAS NOTED TO HAVE ABNORMAL BREATHING AND WAS MOVING, WHICH WAS THOUGHT BY THE PHYSICIAN TO HAVE CAUSED THE PERICARDIAL EFFUSION. THE PHYSICIAN BELIEVED THE PERFORATION OCCURRED DURING ABLATION. THERE WERE NO PERFORMANCE ISSUES WITH THE DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 12028293 ↗
• InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, WHILE IN THE LEFT ATRIUM FOR A PULMONARY VEIN ISOLATION WITH SUBSTRATE MODIFICATION, A STEAM POP OCCURRED DURING ABLATION AND THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DIAGNOSED VIA ULTRASOUND. NO MEDICAL INTERVENTION WAS DEEMED NECESSARY AND THE PATIENT LEFT THE PROCEDURE ROOM IN STABLE CONDITION. THERE WERE NO PERFORMANCES ISSUES WITH THE DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 12008204 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE: 3008452825-2020-00027, 3005334138-2020-00024. DURING A TRICUSPID VALVE ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. FOLLOWING TRANSEPTAL PUNCTURE, SUBSTRATE MAPPING OF THE LEFT VENTRICLE WAS STARTED WITH THE ABLATION CATHETER AND THEN WITH MAPPING CATHETER. AFTER A FEW MINUTES, THE PATIENT BECAME HYPOTENSIVE. ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THE CAUSE AND LOCATION OF THE EFFUSION REMAINS UNKNOWN. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9606611 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC PERFORATION OCCURRED. DURING THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND A TT ECHOCARDIOGRAM CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT WAS FOLLOWED IN THE ICU FOR OBSERVATION. THE PATIENT WAS STABILIZED AND THERE WERE NO FURTHER CONSEQUENCES TO THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9458387 ↗
• InjuryNov 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED WHILE MANEUVERING THE CATHETERS IN THE LEFT ATRIUM. FOLLOWING A SUCCESSFUL TRANSSEPTAL PUNCTURE, THE LEFT ATRIUM ANATOMY WAS COLLECTED WITH THE FLEXIBILITY SENSOR ENABLED ABLATION CATHETER. WHILE MOVING THE DEVICE BETWEEN THE RIGHT SUPERIOR PULMONARY VEIN AND THE LEFT ATRIUM ROOF, AN ABNORMAL VERTICAL MOVEMENT OF THE CATHETER WAS OBSERVED, WHICH LIKELY PERFORATED THE LEFT ATRIUM OR THE VEIN WALL. THE PATIENT BECAME HYPOTENSIVE AND A PERICARDIAL EFFUSION WAS DIAGNOSED WITH ECHOCARDIOGRAPHIC IMAGING. A PERICARDIOCENTESIS WAS PERFORMED WHICH SUCCESSFULLY RESTORED NORMAL ARTERIAL PRESSURE. ECHOCARDIOGRAPHIC IMAGING ALSO CONFIRMED THAT THE EFFUSION WAS COMPLETELY DRAINED. THE PROCEDURE WAS STOPPED AND THE PATIENT WAS STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 9382984 ↗
• InjuryOct 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, AN AORTIC PUNCTURE BY THE TRANSSEPTAL NEEDLE RESULTING IN A PERICARDIAL EFFUSION OCCURRED. FOLLOWING MAPPING OF THE LEFT VENTRICLE IN A RETROAORTIC APPROACH, ACCESS TO THE LEFT VENTRICLE WITH A TRANSEPTAL APPROACH WAS ATTEMPTED. AFTER THE TRANSSEPTAL PUNCTURE THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAPH CONFIRMED A PERICARDIAL EFFUSION. THE PRESSURE DID NOT INCREASE AND THE PATIENT WAS BROUGHT TO SURGERY, WHERE THE AORTA WAS SUTURED TO STABILIZE THE PATIENT. THE NEXT DAY THE PATIENT WAS STABLE WITH NO VISIBLE CONSEQUENCES. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Aortic Dissection; Cardiac Perforation

  MAUDE report 9179222 ↗
• InjuryApr 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 2182269-2019-00044. DURING AN ABLATION PROCEDURE IN THE LEFT ATRIUM, A PERICARDIAL EFFUSION OCCURRED. DURING ABLATION, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 8522342 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE A LEFT BUNDLE BRANCH BLOCK OCCURRED. ONE DAY POSTOPERATIVE THE PATIENT'S EKG SHOWED LEFT BUNDLE BRANCH BLOCK. NO INTERVENTION WAS REQUIRED AND THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Arrhythmia

  MAUDE report 8503291 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3005334138-2019-00044. DURING AN ATRIAL FIBRILLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. WHILE ABLATING IN THE LEFT ATRIUM, THE PATIENT BECAME HYPOTENSIVE. AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8288422 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING AN VENTRICULAR TACHYCARDIA ABLATION PROCEDURE A PERICARDIAL EFFUSION OCCURRED. AT THE END OF THE PROCEDURE ECHOGRAPHY CONFIRMED AN EFFUSION REQUIRING A PERICARDIOCENTESIS. THE EFFUSION OCCURRED DUE TO THE USER INADVERTENTLY ADVANCING THE ABLATION CATHETER IN THE VENTRICLE DURING THE PROCEDURE. THERE WERE NO PATIENT SYMPTOMS NOTED. THERE WERE NO ALLEGED MALFUNCTION WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8254229 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2018-00494. DURING A LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE AN AORTIC DISSECTION OCCURRED. A FLEXIBILITY SE AND ADVISOR HD GRID WERE ADVANCED THROUGH A SHORT FEMORAL ARTERIAL SHEATH FOR THE PROCEDURE. FOLLOWING THE REMOVAL OF THE DEVICES FROM THE FEMORAL ACCESS AND COMPRESSION WAS APPLIED, THE PATIENT LOST SENSATION TO THE RIGHT LEG. A CT SCAN SHOWED AN AORTIC DISSECTION WITH RIGHT LEG EMBOLIZATION NEAR THE FEMORAL ACCESS SITE. VASCULAR SURGERY WAS PERFORMED TO STABILIZE THE PATIENT.

  Patient problems: Aortic Dissection

  MAUDE report 8160997 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, AN EFFUSION OCCURRED. RF WAS DELIVERED IN THE MITRAL ISTHMUS FOR FEW MINUTES AND IN THE POSTERIOR WALL FOR APPROXIMATELY ONE MINUTE. THE PATIENT THEN BECAME HYPOTENSIVE AND A TRANSTHORACIC ECHOCARDIOGRAM REVEALED AN EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED WHICH STABILIZED THE PATIENT.

  Patient problems: Cardiac Perforation

  MAUDE report 8142784 ↗