Lasso Nav D134901Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10846835009651), received between Sep 23, 2019 and Dec 11, 2024 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K113213); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionMay 5, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER AND A STERILIZATION COMPROMISED ISSUE OCCURRED. IT WAS REPORTED THAT THE PRODUCT REACHED THE HOSPITAL WITH SUSPECTED STERILITY VIOLATION. THE STICKER PROTECTING THE BOX HAS BEEN DAMAGED. NO PATIENT INVOLVED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A STERILIZATION COMPROMISED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16882696 ↗
• InjuryFeb 13, 2023Entrapment of Device; Device Contamination with Body Fluid; Patient Device Interaction Problem; Entrapment of Device; Device Contamination with Body Fluid; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH TWO THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETERS AND A LASSO® NAV ECO CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING A PERICARDIOCENTESIS. IT WAS REPORTED THAT AFTER ABLATION WAS CONDUCTED SEVERAL TIMES AFTER INSERTION TO THE PATIENT¿S BODY, SENSOR ERROR (106) OCCURRED. PERICARDIAL FLUID WAS ACCUMULATED AFTER THE PROCEDURE, ABOUT 300 CC OF DRAINAGE WAS PERFORMED. ALSO, THE TRICUSPID REGURGITATION (TR) VALUE AFTER THE PROCEDURE SEEMED TO BE HIGH. THE BIOSENSE WEBSTER REPRESENTATIVE HAD EXPLAINED THAT THE RING CATHETER IS CONTRAINDICATED FOR THE VENTRICLES TO THE PHYSICIAN, BUT THE PHYSICIAN USED THE CATHETER AT THE PHYSICIAN¿S DISCRETION. THE TRICUSPID VALVE WAS CAUGHT DURING RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) MAPPING, AND THE CATHETER COULD BE REMOVED AT THAT TIME, BUT SOME TISSUE WAS ATTACHED TO THE REMOVED RING CATHETER. THE TISSUE WAS SENT FOR BIOPSY. TIMING WHEN COMPLAINTS OCCURRED WAS AFTER THE CATHETER WAS INSERTED INTO THE PATIENT¿S BODY, AND AFTER ABLATION WAS CONDUCTED SEVERAL TIMES, WHEN EFFUSION WAS CONFIRMED AFTER THE PROCEDURE. THE CABLE WAS CHANGED BUT THE ISSUE CONTIN

  Patient problems: Rupture

  MAUDE report 16368686 ↗
• MalfunctionFeb 10, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER AND THERE WAS DAMAGE TO THE INTERIOR PACKAGING OF THE PRODUCT AND STERILITY WAS COMPROMISED. IT WAS REPORTED BY PHYSICIAN THAT THE STERILIZATION PACKAGE WAS BROKEN AND PRODUCT WAS DIRTY. SO THEY DIDN¿T USE THE CATHETER IN/ON PATIENT; THEY REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13507333 ↗
• InjuryJan 18, 2021Entrapment of Device; Detachment of Device or Device Component; Patient Device Interaction Problem; Entrapment of Device; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON (B)(6) 2020 AND A LASSO® NAV ECO CATHETER BECOME ENTRAPPED IN THE VENTRICULAR CHORDAE TENDINEAE REQUIRING SURGICAL INTERVENTION TO BE REMOVED. DURING THE PROCEDURE, WHEN CREATING THE LEFT ATRIAL MODELING, THE LASSO CATHETER FELL INTO THE VENTRICLE AND BECOME ENTRAPPED IN THE CHORDAE TENDINEAE. THE CATHETER COULD NOT BE PULLED OUT. AFTER TWO HOURS OF ROTATING THE CATHETER, IT COULD BE WITHDRAWN FROM THE PATIENT¿S BODY; HOWEVER, THE END OF THE CATHETER WAS BROKEN AND REMAINED ENTRAPPED IN THE CHORDAE TENDINEAE. ON (B)(6) 2020, THE PATIENT UNDERWENT GUIDANCE THORACOSCOPIC SURGERY, AND THE LASSO TIP WAS REMOVED FROM THE PATIENT¿S BODY. ADDITIONAL INFORMATION INDICATED THAT THE KNOB/PISTON WAS UNABLE TO BE TURNED AND/OR PUSHED UP AND DOWN. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SHOULD MORE INFORMATION BECOME AVAILABLE, IT WILL BE REVIEWED AND PROCESSED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11184367 ↗
• MalfunctionJan 14, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER WHERE A POUCH SEAL WAS COMPROMISED. THE INNER PACKAGING OF THE CATHETER WAS DAMAGED BECAUSE OF SOME MISSING GLUE, SO THAT THE STERILITY OF THE PRODUCT WAS COMPROMISED. THIS CATHETER WAS REPLACED WITH ANOTHER ONE AND FROM THE SAME TYPE, SO THAT PROCEDURE WAS FINISHED SUCCESSFULLY. NO PATIENT CONSEQUENCE. THE DEVICE WAS NOT USED ON THE PATIENT. THE DEVICE PACKAGING WAS DISCARDED. THE EVENT WAS ASSESSED AS AN MDR REPORTABLE OPEN POUCH SEAL ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11168571 ↗
• MalfunctionSep 23, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER, AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND EXPOSED WIRES ON THE END OF RING #4. INITIALLY IT WAS REPORTED THAT DURING A RADIO FREQUENCY CATHETER ABLATION PROCEDURE ERROR CODE 106 MAGNETIC SENSOR ERROR CODE WAS DISPLAYED. CATHETER REPLACEMENT RESOLVED THE ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED MAGNETIC SENSOR ERROR 106 ISSUE HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 8/27/2019, THE BWI PAL RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL INSPECTION, THE LASSO LOOP WAS OBSERVED PULLED OFF FROM THE TIP SECTION, LEAVING BROKEN LEAD WIRES EXPOSED FROM THE DISTAL END OF RING#4 AND THE POLYURETHANE SEAL. DURING A SECOND VISUAL INSPECTION, THE BWI PAL FOUND THE LASSO LOOP PULLED OFF THE TIP SECTION, EXPOSING WIRES. THE ISSUE OF EXPOSED BROKEN LEAD WIRES HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION AS DEVICE INTEGRITY WAS NOT MAINTAINED. NO DAMAGES TO BWI PRODUCT WERE REPORTED. FOLLOW UP WAS PERFORMED AND ADDITIONA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9107889 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113213. One submission often covers many models, so check the product and lot details in each record.

• Z-1617-2013 · Jun 19, 2013 · Terminated
  20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.