LASSO NAVRecalls & reported problems across all models

We found 8 models of LASSO NAV by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 131 adverse event reports in the FDA's MAUDE database, received between Aug 30, 2017 and Jul 17, 2025 — classified as 2 deaths, 50 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (27 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LASSO NAV problems

LASSO NAV models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LASSO NAV D134301

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  2 deaths82 reports
• Lasso NAV D134302

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  26 reports
• Lasso Nav D134901

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  11 reports
• LASSO NAV D134903

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  4 reports
• LASSO NAV DLN1215CT

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 reports
• LASSO NAV D134902

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  3 reports
• LASSO NAV D134904

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report
• Lasso Nav D134909

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  1 report

Recent LASSO NAV adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT PRE PULMONARY VEIN ISOLATION (PVI) CARDIAC ABLATION WHILE MAPPING WITH A LASSO NAV CATHETER, THE PATIENT EXPERIENCED A CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. PRE PVI ABLATION, WHILE LEFT ATRIUM (LA) MAPPING WITH A LASSO NAV CATHETER, THE CARDIAC RHYTHM STARTED TO RISE. TRANS THORACIC ECHO REVEALED PERICARDIAC TAMPONADE / PERICARDIAL EFFUSION TREATED WITH A PERICARDIAC PUNCTURE/DRAIN, AND 600ML OF BLOOD WAS REMOVED FROM THE PERICARDIUM. THE PHYSICIAN WAS PAYING ATTENTION TO THE VITAL SIGNS BECAUSE THE TRANSSEPTAL PUNCTURE (TSP) WAS NOT EASY, AND THE POSTERIOR ROOF OF THE LA WAS CLOSE TO THE TSP NEEDLE. THE PATIENT IS STABLE FOR NOW. THE SURGERY WAS DELAYED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Cardiac Tamponade; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22538519 ↗
• MalfunctionMar 27, 2025Improper or Incorrect Procedure or Method; Device Contamination with Body Fluid; Improper or Incorrect Procedure or Method; Device Contamination with Body Fluid

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO NAV AND CHAR WAS FOUND ON THE TIP ELECTRODE. AFTER THE INSERTION OF THE CATHETER IN THE LEFT ATRIUM (LA), THE IMPEDANCE OF THE CORRESPONDING SMART TOUCH SF CATHETER RAPIDLY INCREASED DURING RIGHT PULMONARY VEIN ISOLATION (RPVI). WHEN THE CATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND CHECKED, CHARRING WAS OBSERVED ON THE TIP ELECTRODE OF THE CATHETER. THE SMART TOUCH SF CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. FURTHERMORE, TOWARDS THE END OF THE PROCEDURE, WHEN THE CORRESPONDING LASSO 2515 NAV ECO CATHETER WAS REMOVED FROM THE PATIENT¿S BODY, CHARRING WAS OBSERVED, SIMILAR TO THAT SEEN ON THE SMART TOUCH SF CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WERE NO ERROR MESSAGES PRESENTED BY THE SYSTEM; IMPEDANCE RAPIDLY INCREASED DURING RPVI. THE GENERATOR WAS SET UP ON POWER CONTROL MODE AND ABLATION NEVER CONTINUED BEYOND THE IMPEDANCE CUT-OFF VALUE. THERE WAS USER MISS OF CHANGING THE CATHETER SETTING ON THE GENERATOR SIDE, AND THE ABLATION WAS CONDUCTED WITH THE 4MM TIP CATHETER SETTING DURING 10 TIMES OF ABLATION AT THE BEGINNING. IRRIGATION FLOW RATE WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21713265 ↗
• InjuryFeb 19, 2025Coagulation in Device or Device Ingredient; Patient Device Interaction Problem; Coagulation in Device or Device Ingredient; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSO NAV WHEREIN A THROMBUS/CLOT WAS FOUND ON THE CATHETER TIP AND THE PROCEDURE WAS CANCELLED. THE PATIENT REQUIRED MEDICINAL INTERVENTION AND HOSPITALIZATION. A CLOT WAS DISCOVERED ATTACHED TO THE LASSO NAV CATHETER IN THE LEFT ATRIUM, WHICH WAS NOTICED ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE). THE CLOT FORMATION WAS DISCOVERED AFTER THE INITIAL MAPPING OF THE LEFT ATRIUM. THE PATIENT WAS GIVEN HEPARIN (A LARGE AMOUNT OF HEPARIN TO DILUTE THE CLOT) AND THE PROCEDURE WAS CANCELLED. THERE WAS NO PATIENT INJURY, HOWEVER, THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS THE PATIENT NEEDED NEUROLOGY MONITORING. THE PHYSICIAN HAD SOME DIFFICULTY WHEN THEY TRIED TO GO TRANSSEPTAL AND IT TOOK LONGER THAN USUAL. THE PHYSICIAN BELIEVES THAT EITHER THE PATIENT ALREADY HAD A CLOT THAT THEY DIDN'T NOTICE OR THE CLOT WAS CAUSED BY THE 45 MINS IT TOOK TO GO TRANSSEPTAL. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT USE HEPARIN UNTIL POST TRANSSEPTAL, HE ALSO DOES NOT CLEAR THE LEFT ATRIAL APPENDAGE (LAA) WITH "SOUND" (ULTRASOUND). THERE WAS NO ERROR MESSAGE FROM THE EQUIPMENT, NO PRODUCT PROBLEM, OR ANY ISSUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415057 ↗
• MalfunctionDec 11, 2024Display or Visual Feedback Problem; Material Protrusion/Extrusion; Display or Visual Feedback Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER AND DURING THE OPERATION, THE DEVICE WAS RECOGNIZED BY THE CARTO BUT THE CATHETER WAS NOT VISUALIZED ON THE CARTO SYSTEM. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. POST PROCEDURE, THE MEDICAL TEAM IDENTIFIED THAT INTERNAL COMPONENTS WERE EXPOSED ON THE TIP. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904803 ↗
• MalfunctionSep 6, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A LASSO NAV CATHETER AND OBSERVED FOREIGN MATERIAL AT THE TIP OF THE CATHETER. DURING THE PROCEDURE, AFTER WITHDRAWAL OF THE CATHETER FROM THE PATIENT, FOREIGN MATERIAL WAS FOUND AT THE TIP OF THE CATHETER. A SECOND CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157259 ↗
• MalfunctionAug 15, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO NAV AND THE LASSO CAPACITY TO CHANGE THE CURVE WAS BROKEN. THE PHYSICIAN COULD NOT MOVE IT. THEY HAD TO EXCHANGE THE CATHETER. NO PATIENT CONSEQUENCE WAS REPORTED. WITH THE INITIAL INFORMATION RECEIVED, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE. HOWEVER, ON 22-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED WHICH MADE THE EVENT MDR REPORTABLE WITH AN AWARENESS DATE OF 22-JUL-2024. IT WAS REPORTED THAT DURING THE PROCEDURE, THE LASSO COULD NO LONGER BE FOLDED BACK (LOCKED IN THE OPEN POSITION). ACCORDING TO THE DOCTOR, THIS MADE HANDLING TOO COMPLICATED, WHICH IS WHY THE PROBE HAD TO BE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997251 ↗
• MalfunctionJul 10, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSO NAV CATHETER AND THERE WAS ELECTROCARDIOGRAM (ECG) SIGNAL INTERFERENCE. DURING THE OPERATION, THE SIGNAL INTERFERENCE (NOISE) WAS OBSERVED ON ALL BODY SURFACE AND INTRACARDIAC ECG CHANNELS. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RECEIVED FOR ANALYSIS, AND IT WAS DISCOVERED THAT ELECTRODE #1 WAS LIFTED WITH SHARP EDGES. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710514 ↗
• MalfunctionJul 8, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH A LASSO® NAV ECO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE FIRST ELECTRODE DETACHED FROM ITS POSITION AND OBSERVED LIFTED THE ELECTRODE. DURING THE PROCEDURE, THE DEVICE WAS RECOGNIZED BY THE CARTO BUT THE CATHETER ELECTRODE WAS NOT VISUALIZED ON THE CARTO SYSTEM. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 11-JUN-2024, THE FIRST ELECTRODE WAS DETACHED FROM ITS POSITION AND OBSERVED LIFTED THE ELECTRODE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE FIRST ELECTRODE DETACHED FROM ITS POSITION AND OBSERVED LIFTED THE ELECTRODE ON 11-JUN-2024 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19689546 ↗
• InjuryMay 21, 2024Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION WITH A LASSO® NAV ECO CATHETER AND THE PATIENT EXPERIENCED SOFT TISSUE INJURY AND MEDICAL DEVICE ENTRAPMENT. THE PHYSICIAN FOUND THEIR PROGRESS WITH THE LASSO TO BE IMPEDED. THE LASSO WAS HOOKED TO THE NON-SURROUNDING TISSUE OF THE FORAMEN OVALE WHEN WITHDRAWING FROM THE LEFT ATRIUM TO THE RIGHT ATRIUM, RESULTING IN THE CATHETER'S INABILITY TO BE WITHDRAWN. FINALLY, "USE [OF] EXTERNAL FORCE TO DIRECTLY PULL OUT THE CATHETER," IT WAS FOUND THAT THE HOOK HAD BROUGHT OUT SOME MYOCARDIAL TISSUE. THE PHYSICIAN ATTRIBUTES THE EVENT TO A MALFUNCTION WITH THE LASSO.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19361334 ↗
• MalfunctionApr 10, 2024Break; Mechanical Jam; Break; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE SPIRAL OF THE CATHETER BROKE. THE LOOP OF THE CATHETER WAS BLOCKED. IT WAS NOT POSSIBLE TO MANIPULATE THE CATHETER. SO THE MEDICAL TEAM CHANGED IT AND EVERYTHING WENT WELL WITH THE REMAINDER OF THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085017 ↗
• MalfunctionMar 11, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER. IMMEDIATELY AFTER INSERTION, BECAME INOPERABILITY AT THE TIMING WHEN DECREASED THE RING DIAMETER IMMEDIATELY. THE ISSUE WAS RESOLVED BY REPLACING THE LASSO® NAV ECO VARIABLE CATHETER. PATIENT WAS UNAFFECTED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS SOME RESISTANCE. THERE WAS NO RING, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18882376 ↗
• InjuryMar 5, 2024Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A SUPRAVENTRICULAR TACHYCARDIA (SVT) CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A LASSO® NAV ECO VARIABLE CATHETER AND THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AFIB) TREATED WITH CARDIOVERSION. IT WAS REPORTED THAT WHEN INSERTING THE LASSONAV CATHETER, THE PATIENT WENT INTO AFIB. THE PHYSICIAN FEELS THAT THE ISSUE IS RELATED TO THE CATHETER FREQUENCIES ON THE CARTO 3 SYSTEM. PATIENT HAS FULLY RECOVERED.

  Patient problems: Atrial Fibrillation

  MAUDE report 18840804 ↗
• MalfunctionFeb 29, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE PRODUCT WAS FULL OF BLOOD ON THE OUTSIDE. A REQUEST FOR CLARIFICATION IS BEING REQUESTED. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808852 ↗
• MalfunctionFeb 25, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO VARIABLE CATHETER AND THE TORQUE TO CONTROL THE LOOP FAILED. AFTER MAPPING WITH THE LASSO® NAV ECO VARIABLE CATHETER, HE TRIED TO RELEASE THE LOOP AND PUT IT IN VEIN TO CHECK THE SIGNAL FOR ABLATION, BUT THE TORQUE TO CONTROL THE LOOP FAILED, SO HE WAS ABLE TO REPLACE IT WITH A NEW CATHETER AND SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775156 ↗
• InjuryJan 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND LASSO® NAV ECO VARIABLE CATHETER. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. CARDIAC TAMPONADE OCCURRED. PUNCTURE WAS PERFORMED AND THE CORONARY SINUS CATHETER WAS PLACED THROUGH THE NECK. BROCKEN BROUGH WAS PERFORMED. AFTER "SS MERGE" AND PRE MAP WERE PERFORMED IN THE LEFT ATRIUM (LA), HYPOTENSIVE WAS FOUND. DRAINAGE WAS PERFORMED. DURING THE DRAINAGE, PULMONARY VEIN ISOLATION (PVI) WAS PERFORMED. AFTER ONLY PVI, THE ABLATION WAS TERMINATED. PROLONGED DRAINAGE COULD NOT STABILIZE THE PATIENT¿S CONDITION VERY MUCH. THE TIMING WAS AFTER TWO HOURS FROM THE ROOM ENTRY. THE PATIENT LEFT THE ROOM FOR A CT SCAN. THE CAUSE WAS UNKNOWN. PHYSICIAN ASSESSMENT OF THE HEALTH PROBLEM WAS SERIOUS. THERE WERE NO ABNORMALITIES OBSERVED BEFORE USING THE PRODUCT AND WHILE USING THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE EVENT OCCURRED DURING THE MAPPING PHASE. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH RF NEEDLE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT COULD NOT BE DETERMINED, BUT IT WAS POSSIBLY PROCEDURE RELA

  Patient problems: Cardiac Tamponade

  MAUDE report 18531990 ↗

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