Advisor™ D-AVSE-DF10-F20Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05415067025968), received between Jul 10, 2018 and Sep 30, 2023 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2023Material Separation; Material Separation

  DURING THE ATRIAL FIBRILLATION PROCEDURE, THE ADVISOR FL MAPPING CATHETER WAS USED FOR POST CRYO ABLATION MAPPING. THE ADVISOR FL MAPPING CATHETER WAS INSERTED IN A SWARTZ BRAIDED INTRODUCER AND THEN IT WAS INSERTED INTO A NON-ABBOTT SHEATH (MEDTRONIC FLEXCATH) TO PERFORM MAPPING. THE ADVISOR FL MAPPING CATHETER WAS THEN INSERTED BACK INTO THE SWARTZ BRAIDED INTRODUCER. WHEN THE ADVISOR FL MAPPING CATHETER WAS REMOVED FROM THE PATIENT'S BODY, THE CATHETER COATING WAS BROKEN AND THE LEAD WIRE WAS EXPOSED. THE ADVISOR FL MAPPING CATHETER WAS REPLACED AND SINCE THE DAMAGED CAPSULE REMAINED IN THE SWARTZ BRAIDED INTRODUCER, IT WAS ALSO REPLACED. THE PROCEDURE THEN PROCEEDED WITH NO ADVERSE PATIENT CONSEQUENCES. THERE WERE NO ALLEGED ISSUES WITH THE SWARTZ BRAIDED INTRODUCER. A POST-OPERATIVE MRI WAS COMPLETED, AND NO RESIDUAL FINDINGS WERE FOUND IN THE CEREBRAL BLOOD VESSELS. ALTHOUGH IT CANNOT BE SURE, FOUND THAT WHAT APPEARED TO BE REMNANTS IN THE RIGHT ATRIUM. THE PATIENT IS CURRENTLY UNDER FOLLOW-UP OBSERVATION. A CHECK OF THE SHEATH AT THIS TIME REVEALED NO EXTERNAL DAMAGE. THERE WAS NO RESISTANCE DURING THE PROCEDURE, AND THE USER DID NOT FORCE THE OPERATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17849323 ↗
• MalfunctionJul 14, 2023Entrapment of Device; Entrapment of Device

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE ADVISOR HD GRID CATHETER BECAME ENTANGLED WITH THE ADVISOR FL IN THE LEFT ATRIUM AND THE CATHETERS COULD NOT BE REMOVED. WHEN ATTEMPTING TO REMOVE THE CATHETERS USING A SNARE, A ATRIAL SEPTAL DEFECT DEVELOPED UPON EXITING THE RIGHT ATRIUM AND THE CATHETERS WERE SUCCESSFULLY REMOVED USING AN ABLATION CATHETER. PULMONARY VEIN ISOLATION WAS PERFORMED, AND THE PROCEDURE WAS COMPLETED WHICH TOOK APPROXIMATELY 2 HOURS LONGER THAN USUAL. THE CATHETERS WERE REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17324687 ↗
• MalfunctionMar 9, 2023Fracture; Difficult to Insert; Improper or Incorrect Procedure or Method; Fracture; Difficult to Insert; Improper or Incorrect Procedure or Method

  DURING AN ATRIAL FIBRILLATION PROCEDURE, THE CATHETER BECAME STUCK IN THE SHEATH. WHEN ATTEMPTING TO INSERT THE MAPPING CATHETER INTO THE SHEATH WITHOUT USING THE INSERTION AID, THE TIP BECAME STUCK IN THE SHEATH. THE INSERTION AID WAS ADVANCED AFTERWARDS AND THE TIP OF THE CATHETER WOULD NOT MOVE FORWARD OR BACKWARD. THE PHYSICIAN THEN PULLED THE INSERTION AID AND CATHETER TIP OUT OF THE SHEATH AND THE TIP OF THE CATHETER TORE OFF. THE SHEATH WAS PULLED OUT OF THE PATIENT TO ENSURE THAT NO FRAGMENT OF THE CATHETERS REMAINED IN THE PATIENT. THE CATHETER AND THE SHEATH WERE REPLACED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16513137 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, A TAMPONADE OCCURRED. WHILE MAPPING THE RIGHT UPPER PV, THE PATIENT BECAME HYPOTENSIVE AND A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A CARDIAC TAMPONADE. THE PATIENT WAS INTUBATED AND A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. PATIENT IS CURRENTLY IN STABLE CONDITION AND IS RECOVERING. THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICES.

  Patient problems: Cardiac Perforation

  MAUDE report 10894881 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURING RELATED REF: 3005334138-2019-00372, 3008452825-2019-00329, 3005334138-2019-00371. DURING THE PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. AN ICE CATHETER WAS USED TO VIEW THE VENTRICLES AND PERICARDIUM THROUGHOUT THE PROCEDURE AND THE USER NOTED A SMALL EFFUSION DEVELOPING DURING THE LEFT VEIN WIDE ATRIAL CIRCUMFERENTIAL ABLATION. THE EFFUSION WAS IN THE LEFT ATRIUM AND THE PATIENT EXPERIENCED REDUCED BLOOD PRESSURE AND CARDIAC TAMPONADE. THE PROCEDURE WAS STOPPED AND PROTAMINE WAS ADMINISTERED AND A PERICARDIOCENTESIS WAS PERFORMED WITH THE PLACEMENT OF A PERICARDIAL DRAIN. THERE WERE NO PERFORMANCE ISSUES WITH AN ABBOTT DEVICE.

  Patient problems: Cardiac Perforation; Cardiac Tamponade

  MAUDE report 8781822 ↗
• InjuryJun 24, 2019Difficult to Remove; Difficult to Remove

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE THE CIRCULAR MAPPING CATHETER BECAME ENTANGLED AROUND THE CATHETER SHAFT AND WAS UNABLE TO BE WITHDRAWN THROUGH THE SHEATH. A SNARE CATHETER WAS USED TO RESOLVE THE ISSUE. THE CATHETER WAS REMOVED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT, BUT DID PROLONG THE PROCEDURE BY 45 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727172 ↗
• InjuryMar 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REFERENCE: 3008452825-2019-00118, 3005334138-2019-00155, 3005334138-2019-00164. FOLLOWING AN ATRIAL FIBRILLATION ABLATION PROCEDURE A CARDIAC PERFORATION OCCURRED. THE PERFORATION WAS LOCATED IN THE LEFT ATRIUM NEAR THE LEFT ATRIAL APPENDAGE. A PERICARDIOCENTESIS WAS DONE TO STABILIZE THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR OBSERVATION.

  Patient problems: Cardiac Perforation

  MAUDE report 8457249 ↗
• InjuryFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURING REF: 3008452825-2019-00041, 3008452825-2019-00043, 3008452825-2019-00044, 3005334138-2019-00050, 3005334138-2019-00051, 3008452825-2019-00045, 3005334138-2019-00052. FOLLOWING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION WAS NOTED VIA ECHOCARDIOGRAPHY. A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT. NO PATIENT SYMPTOMS WERE NOTED THROUGHOUT THE PROCEDURE AND THERE WERE NO PERFORMANCE ISSUES WITH ANY ABBOTT DEVICE.

  Patient problems: Cardiac Perforation

  MAUDE report 8304844 ↗
• MalfunctionNov 13, 2018Material Separation; Material Separation

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A GAP BETWEEN THE SHAFT MATERIAL AND THE TIP ELECTRODE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063671 ↗
• InjuryJul 10, 2018Difficult to Remove; Difficult to Remove

  DURING A PULMONARY VEIN ISOLATION PROCEDURE A CLINICALLY SIGNIFICATION DELAY OCCURRED. DURING LEFT ATRIAL GEOMETRY COLLECTION THE ADVISOR CATHETER WAS ADVANCED INTO THE LEFT VENTRICLE AND BECAME ENTANGLED IN THE MITRAL VALVE. THE CATHETER WAS DIFFICULT TO REMOVE ONCE ENTANGLED AND TOOK AN HOUR UNTIL THE TIP OF THE CATHETER WAS RELEASED AND PULLED BACK INTO THE ATRIUM. THE PATIENT EXPERIENCED NO ADVERSE CONSEQUENCES TO THE MITRAL ANNULUS AND THE PROCEDURE WAS COMPLETED WITH A CATHETER REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7674020 ↗