Lassostar NAV D140402Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10846835020342), received between Nov 23, 2022 and Aug 15, 2024 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION ABLATION WITH A LASSOSTAR NAV CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. PERICARDIAL TAMPONADE DURING THE PROCEDURE. THE DOCTOR IS NOT SURE WHETHER IT HAPPENED WHILE MANEUVERING THE CATHETER IN THE LEFT ATRIUM OR DURING THE ABLATION. IT WAS ABLATED WITH 15W 45S (15S POSTERIOR). THE PROCEDURE WAS STOPPED WHEN THE EVENT OCCURRED. THE BLOOD HAD TO BE REMOVED VIA A PERICARDIAL PUNCTURE. THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT FULLY RECOVERED. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT.

  Patient problems: Cardiac Tamponade

  MAUDE report 19996314 ↗
• InjuryApr 2, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. AFTER THE CRYO PORTION OF THE CASE, WHILE MAPPING WITH THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER ON THE POSTERIOR WALL AND ROOF OF THE LEFT ATRIUM, THE ANESTHESIOLOGIST REPORTED THAT THE PATIENT HAD LOW BLOOD PRESSURE. INTRACARDIAC ECHO (ICE) REVEALED AN EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, REMOVING 700 CC OF FLUID. THE PATIENT WAS STABLE AT THE TIME OF THE CALL. THE PHYSICIAN USED A BWI ABLATION CATHETER TO ABLATE THE CAVOTRICUSPID ISHMUS (CTI) LINE IN THE RIGHT ATRIUM (RA), AND WAS ABOUT TO ABLATE ON THE LA ROOF WHEN THE LOW BLOOD PRESSURE WAS REPORTED. THE PHYSICIAN STATED THAT THEY BELIEVED THE ISSUE OCCURRED WHILE MAPPING THE ROOF WITH THE LASSOSTAR CATHETER. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT THAT IT WAS BWI PRODUCT MALFUNCTION. DOCTOR CLAIMED HE THINKS THAT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER POKED THROUGH THE ROOF. BUT IT IS REALLY UNKNOWN AS NUMEROUS EVE

  Patient problems: Cardiac Tamponade

  MAUDE report 19029718 ↗
• MalfunctionJan 19, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE SHAFT WAS BENT WITH INTERNAL COMPONENTS EXPOSED. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER COULD NOT BE INSERTED INTO THE HELIOSTAR. IT FELT LIKE THE HELIOSTAR LUMEN WAS BLOCKED. DUE TO THE PRESSURE ON THE LASSO WHEN INSERTING IT, THE LASSO IS BENT IN ONE PLACE. THE PROBLEM WAS SOLVED BY USING A NEW LASSO. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT HARM TO THE PATIENT. THE CUSTOMER¿S REPORTED ISSUE OF RESISTANCE AND BENT SHAFT ARE NOT CONSIDERED TO BE MDR REPORTABLE MALFUNCTIONS SINCE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 27-DEC-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND SHAFT WAS BENT WITH INTERNAL COMPONENTS EXPOSED. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF ¿INTERNAL COMPONENTS EXPOSED¿ AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544368 ↗
• MalfunctionNov 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED DAMAGE ON AN ELECTRODE (PARTIALLY SEPARATED FROM THE TIP) AND SHAFT ON THE LOOP BROKEN WITH INTERNAL WIRES EXPOSED. THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER GOT A DEFECT DURING PULLING IT OUT FROM THE PATIENT. THERE WAS NO FRAGMENT GENERATED DURING THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER WAS NOT SWITCHED. THEY TRIED TO PULL OUT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER FROM THE BALLOON BECAUSE CONTRAST MEDIUM DELIVERY WAS NOT POSSIBLE. WHEN THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER WAS PULLED OUT, A LASSOSTAR NAV CIRCULAR MAPPING CATHETER DEFECT PROBABLY OCCURRED DUE TO THE TIGHTENING. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 07-NOV-2023, KINKS WERE OBSERVED ALONG THE SHAFT, DAMAGE ON ONE OF THE ELECTRODES (PARTIALLY SEPARATED FROM THE TIP) AND THE SHAFT ON THE LOOP WAS OBSERVED BROKEN WITH INTERNAL WIRES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243829 ↗
• MalfunctionAug 22, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND A RIPPED CATHETER ISSUE OCCURRED. DURING INSERTION OF THE LASSOSTAR INTO THE Y-CONNECTOR, THE LASSOSTAR GOT STUCK AFTER ABOUT 3CM. WHEN PULLING THE LASSOSTAR OUT, IT RIPPED. A NEW Y-CONNECTOR AND A NEW LASSOSTAR WE¿RE NEEDED. THE SURGERY WAS DELAYED BY FIVE MINUTES. ADDITIONAL INFORMATION WAS RECEIVED ON 03-AUG-2023. IT RIPPED WHILE TRYING TO INTRODUCE INTO THE HELIOSTAR. THERE WAS VISIBLE DAMAGE ON THE SHAFT OF THE CATHETER. THERE IS NO PICTURE AVAILABLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599819 ↗
• MalfunctionJul 25, 2023Material Protrusion/Extrusion; Material Twisted/Bent; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED ABLATION PROCEDURE WITH A LASSOSTAR¿ NAV CIRCULAR MAPPING CATHETER AND DUE TO RESISTANCE 4 LASSOSTARS WERE EITHER PHYSICALLY DAMAGED OR PROVIDED AN ERROR 116 FORCE SENSOR ERROR. IT WAS CONFIRMED THAT TWO OF THE LASSOSTARS HAD A KINKED SHAFT AND BROKEN SENSOR. NO PATIENT CONSEQUENCES WERE REPORTED. NO FURTHER PROCEDURAL DETAILS WERE PROVIDED. THE KINKED SHAFT IS NOT MDR-REPORTABLE. THE (PHYSICALLY) BROKEN SENSOR IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17394054 ↗
• MalfunctionFeb 24, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTARNAV,10P,15MM DIA LOOP. IT WAS REPORTED THAT DURING A PROCEDURE, WHILE IN THE RIGHT VEINS, THE LASSO "CATHETER KEPT GETTING STUCK WITH THE BALLOON." THEY REPORTED THAT WHEN THEY PULLED THE CATHETER BACK, IT GOT FRAYED AND THE ELECTRODES BROKE OFF IN THE SHEATH. TO TROUBLESHOOT THE MEDICAL TEAM PULLED OUT THE CATHETER. THEY OPENED A NEW LASSO CATHETER, BUT IT WAS EXPERIENCING RESISTANCE, THE PHYSICIAN FELT UNCOMFORTABLE PROCEEDING WITH THE REPLACEMENT LASSO CATHETER, SO THEY REPLACED IT WITH A CRYO-CATHETER. THE ISSUE WAS RESOLVED, AND THE PROCEDURE IS BEING CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. THE DAMAGE RESULTED IN WIRES AND/OR BRAID BEING EXPOSED. THEY WEREN¿T SURE IF THE DAMAGE RESULTED IN ANY LIFTED OR SHARP RINGS. THE PHYSICIAN REMOVED THE DETACHED SECTION. VIDEO ATTACHED ON EMAIL FOR PICTURE PURPOSES. THE SHEATH / HELIOSTAR WAS IN THE DEFLECTED STATE. 3 RINGS WERE OBSERVED WITH DAMAGE. THE RESISTANCE WAS FELT DURING RETRACTION OF THE CATHETER. THE REPORTED LOT NUMBER 30941558L WAS THE FIRST USED CATHETER THAT HAD ELECTRODES BROKE OFF IN THE SHEATH ISSUE. RESIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16439382 ↗
• MalfunctionNov 23, 2022Failure to Sense; Material Separation; Failure to Sense; Material Separation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND CATHETER SHAFT APPEARED TO BREAK WHILE IN USE INSIDE THE PATIENT. IT WAS REPORTED THERE WAS AN ERROR 116 (20 POLE A: CATHETER SENSOR ERROR) AND THE SYSTEM COULDN´T DETECT THE CATHETER. THIS CATHETER WAS NOT REPLACED WITH ANOTHER ONE BECAUSE THE PHYSICIAN WANTED TO USE THE SAME CATHETER DUE TO AIR MANAGEMENT. THEY WERE NO NOISE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT DELAY AND THERE WAS NO PATIENT CONSEQUENCE. AFTER THE CASE, THE PHYSICIAN TOOK A LOOK AT THE CATHETER AND SAW THAT THE CATHETER WAS PHYSICALLY BROKEN. THE CUSTOMER¿S REPORTED SENSOR ERROR IS NOT CONSIDERED TO BE MDR REPORTABLE AS THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15851213 ↗