LASSO NAV D134903Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835009675), received between Feb 3, 2020 and Dec 28, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 28, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER AND A KNOTTED LOOP ISSUE OCCURRED. IT WAS REPORTED THAT THE LASSO CATHETER WAS "TWISTING ON ITSELF" AND THE PHYSICIAN REPORTED THAT THE HANDLE WAS NOT ABLE TO MANEUVER PROPERLY. WHEN THE CATHETER WAS REPLACED, THE ISSUE RESOLVED. REPLACEMENT CATHETER REQUESTED. SHEATH INFORMATION WAS A MERIT 90-DEGREE FIXED SHEATH, 8.5 FRENCH. THERE WAS NO DETACHMENT OF ANY COMPONENT. THE STATEMENT "TWISTING ON ITSELF¿ WAS CONFIRMED TO MEAN THAT AS THE PHYSICIAN WAS CLOCKING THE CATHETER, THE LASSO LOOP BECAME TWISTED AND DISFIGURED, NOT FORMING THE NORMAL LOOP SHAPE. THE LOOP/TIP BECAME UNKNOTTED. THE ISSUE DID NOT RESULT IN EXPOSURE OF ANY INTERNAL CATHETER COMPONENTS OR SHARP EDGES. IMAGE ON FLUORO IS NOT AVAILABLE. THE PHYSICIAN STATED THAT THE CATHETER WAS MOVING IN THE WAY HE WAS ACCUSTOMED TO. THE KNOTTED LOOP ISSUE IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16064915 ↗
• MalfunctionNov 22, 2021Signal Artifact/Noise; Material Split, Cut or Torn; Signal Artifact/Noise; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION PROCEDURE WITH A LASSO® NAV ECO CATHETER, AND THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB OBSERVED A LASSO LOOP BROKEN ISSUE. INITIALLY THE LASSO® NAV ECO CATHETER (LOT 30499595L) HAD A SIGNAL NOISE WHICH OCCURRED AT THE 7-8, 9-10 ON BOTH THE CARTO 3 SYSTEM AND THE LAB2 WHEN PLACED IN THE PATIENT¿S BODY. THE CABLE WAS RECONNECTED AND CHANGED BUT THE ISSUE CONTINUED. THE LASSO® NAV ECO CATHETER WAS CHANGED AND THE ISSUE RESOLVED. THE PROCEDURE COULD BE CONTINUED AND COMPLETED WITHOUT PATIENT CONSEQUENCE. THE SIGNAL NOISE ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE RISK TO THE PATIENT WAS LOW. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2021 THE RETURNED SAMPLE REVEALED DAMAGE AT THE TIP AREA ON THE LASSO® NAV ECO CATHETER AS INTERNAL COMPONENTS WERE EXPOSED AND ELECTRODES 1 AND 2 WERE FORCEFULLY MOVED FROM THEIR ORIGINAL PLACE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS RETURNED CONDITION. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THIS RETURNED CONDITION WAS ASSESSED AS MDR REPORTABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858749 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT (67 YEAR OLD, 71KG) UNDERWENT PAROXYSMAL (AFIB) ABLATION PROCEDURE WITH LASSO® NAV ECO CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE PATIENTS' PRESSURE DROPPED AND A PERICARDIAL EFFUSION WAS DIAGNOSED VIA (ICE) INTRACARDIAC ULTRASOUND. THE CALLER STATED THAT THE LEFT ATRIAL APPENDAGE (LAA) WAS PERFORATED WHEN MANEUVERING THE LASSO CATHETER. A PERICARDIOCENTESIS WAS PERFORMED BY THE PHYSICIAN. AN APPENDAGE CLOSURE DEVICE (LARIAT) WAS BEING INSERTED AT THE TIME OF THE CALL. THE CATHETER WAS DISCARDED. IN THE PHYSICIAN¿S OPINION, THE CAUSE OF THIS ADVERSE EVENT WAS RELATED TO PATIENT ANATOMY. AN APPENDAGE CLOSURE DEVICE (LARIAT) WAS ATTEMPTED TO LIGATE THE LAA BUT FAILED. PATIENT WAS THEN TAKEN FOR SURGICAL REPAIR. THE PATIENT HAD IMPROVED AND ALMOST FULLY RECOVERED. AN EXTENDED HOSPITAL STAY WAS REQUIRED DUE TO THE SURGICAL REPAIR. THE EVENT OCCURRED DURING INITIAL MAPPING. TRANSSEPTAL WAS PERFORMED WITH BRK NEEDLE (ABBOTT). NO ABLATION WAS PERFORMED PRIOR TO THE DISCOVERY OF THE EFFUSION. THERE WAS NO EVIDENCE OF STEAM POP. SINCE THIS EVENT MAY BE LIFE THREATENING; MIG

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 10532704 ↗
• InjuryFeb 3, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE ON WHICH A LASSO NAV CATHETER WAS USED, AND A MEDICAL DEVICE ENTRAPMENT OCCURRED REQUIRING SURGICAL INTERVENTION. DURING THE MAPPING PHASE OF THE LEFT ATRIUM, THE LASSO CATHETER ACCIDENTLY WENT FROM THE MITRAL VALVE INTO THE LEFT VENTRICLE. ALL ATTEMPTS TO GET THE LASSO BACK INTO THE LEFT ATRIUM FAILED. THE PATIENT REQUIRED SURGICAL INTERVENTION SO THE CATHETER COULD BE RETRIEVED FROM THE HEART. THERE¿S NO INFORMATION REGARDING EXTENDED HOSPITALIZATION, PATIENT¿S OUTCOME, OR THE PHYSICIAN¿S CAUSALITY OPINION. THE CATHETER WAS NOT STUCK OR JAMMED IN A FULL DEFLECTED POSITION. THE KNOB/PISTON WAS NOT UNABLE TO BE TURNED AND/OR PUSHED UP AND DOWN. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9661856 ↗

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.