Lassostar NAVRecalls & reported problems across all models

We found 3 models of Lassostar NAV by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2022 and Dec 5, 2024 — classified as 4 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 Lassostar NAV problems

Lassostar NAV models

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

• Lassostar NAV D140401

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  24 reports
• Lassostar NAV D140402

  CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
  8 reports
• Lassostar NAV D140403

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

Recent Lassostar NAV adverse event reports

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

• MalfunctionDec 5, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Off-Label Use; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) CARDIAC PROCEDURE WHICH INCLUDED THE USE OF A LASSOSTAR NAV FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THAT ONE OF THE ELECTRODES WAS LIFTED WITH INTERNAL COMPONENTS EXPOSED. INITIALLY, IT WAS REPORTED THAT WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE LASSOSTAR CATHETER THROUGH THE CRYO SHEATH, IT WAS UNABLE TO BE REMOVED. THE SHEATH AND CATHETER WERE THEN REMOVED FROM THE BODY TOGETHER. THE LASSONAV DISTAL TIP WAS LODGED IN THE SHEATH TOWARDS THE PROXIMAL END OF THE SHEATH AT THE HUB. AFTER THE CASE, THE SCRUB TECH WAS ABLE TO PULL AND REMOVE THE CATHETER FROM THE SHEATH. NO DAMAGE WAS NOTED ON THE CATHETER AND NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE EVENT WAS ASSESSED AS NON MDR REPORTABLE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION, THE SHAFT WAS OBSERVED BENT AND ONE OF THE ELECTRODES WAS LIFTED WITH INTERNAL COMPONENTS EXPOSED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 09-NOV-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20858453 ↗
• MalfunctionOct 31, 2024Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV AND THE LASSO STAR PACKAGING WAS DAMAGED ON THE INSIDE OF THE BOX. THE STAFF HAD DIFFICULTY OPENING THE PACKAGE AND THE CATHETER WAS CONTAMINATED AS A RESULT. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582254 ↗
• MalfunctionSep 20, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND POST PROCEDURE THE BWI PRODUCT ANALYSIS LAB IDENTIFIED A DAMAGE ON SHAFT AND INTERNAL PARTS WERE EXPOSED. DURING THE CRYOABLATION, THE CATHETER WOULD NOT FIT THROUGH THE BALLOON AND BECAME BENT. THERE WAS RESISTANCE DURING INSERTION. THERE WERE NO WIRES EXPOSED OR LIFTED/SHARPENED RINGS. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20270036 ↗
• MalfunctionSep 11, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV AND THE CATHETER TIP BROKE INTO PIECES. IT WAS REPORTED BY THE CALLER THAT THE LASSOSTAR NAV CATHETER THAT THE PHYSICIAN STATED THE CATHETER WAS HARD TO MANEUVER. UPON REMOVING THE CATHETER IT APPEARED TO BE KINKED TO THE POINT THAT IT WAS DIFFICULT TO REMOVE FROM THE BALLOON. AND RESULTED IN THE DISTAL END OF THE CATHETER BEING STRIPPED FROM THE BALLOON AND BREAKING INTO PIECES ONCE IT WAS PULLED OUT OF THE PATIENT. THE WAS NO PATIENT CONSEQUENCE. THE PHYSICIAN DECIDED TO NOT USE THE CRYO BALLOON AND THE LASSOSTAR CATHETER AND SWITCHED TO RF ABLATION. THE CASE CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197387 ↗
• 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 ↗
• MalfunctionAug 6, 2024Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND THE DEVICE BROKE ON THE DISTAL SIDE WHILE INSIDE THE PATIENT. THE CATHETER WAS REPLACED. IT TOOK 10 MINUTES TO RESOLVE THE ISSUE. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19922772 ↗
• MalfunctionJun 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN 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 BROKEN CLOSE TO THE TIP TRANSITION. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER KNICKED WHILE LEADING HIM INTO THE HELIOSTAR. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER. THE ISSUE WAS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 16-MAY-2024, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE SHAFT WAS BROKEN CLOSE TO THE TIP TRANSITION. THESE FINDING WAS REVIEWED AND ASSESSED THE ISSUE AS AN MDR REPORTABLE MALFUNCTION SINCE THE INTEGRITY OF THE DEVICE IS COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19525332 ↗
• 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 ↗
• MalfunctionFeb 26, 2024Device-Device Incompatibility; Material Protrusion/Extrusion; Device-Device Incompatibility; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND THE ELECTRODES AND THE MATERIAL COVERING THE TIP OF THE LASSO WERE DAMAGED AS THEY EXITED THE BALLOON LUMEN. IT WAS IMPOSSIBLE TO ASSEMBLE THE LASSOSTAR NAV UNTIL IT CAME OUT OF THE HELIOSTAR BALLOON DURING PREPARATION BEFORE INTRODUCING IT INTO THE PATIENT. THEY FOUND THAT THERE WAS RESISTANCE ON BOTH WHEN FITTING IT INTO THE BALLOON AND WHEN REMOVING IT. THE ELECTRODES AND THE MATERIAL COVERING THE TIP OF THE LASSO WERE DAMAGED AS THEY EXITED THE BALLOON LUMEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784409 ↗
• MalfunctionFeb 15, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND DURING CASE SETUP ON THE BACK TABLE, WHILE INSERTING THE CATHETER THROUGH THE HEMOSTATIC VALVE, THERE WAS A "WEAK" POINT WHERE THE OUTER CASING OF THE CATHETER SHEARED OFF. THERE WERE SHARP EDGES AT THE SHEER POINT. THE INTERNAL WIRES WERE EXPOSED. THE AFFECTED AREA WAS ABOUT 6 INCHES BEFORE THE LOOP--THERE WAS A TRANSITION OF METAL MATERIAL IN THIS AREA. SINCE THE CATHETER HAS A PRE SHAPED LASSO STYLE LOOP, A STRAIGHTENING INTRODUCER WAS USED TO STRAIGHTEN THE LOOP BEFORE TRYING INSERTION. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18716778 ↗
• 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 ↗
• MalfunctionJan 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE SHAFT AND TIP WITH A WRINKLED TEXTURE, AND ELECTRODE LIFTED WITH EDGES. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE LASSOSTAR NAV CIRCULAR MAPPING CATHETER HAS BECOME STUCK INSIDE THE LUMEN OF THE HELIOSTAR BALLOON CATHETER. THERE WAS NO PATIENT CONSEQUENCE AND NO OTHER DETAILS ABOUT THE EVENT WERE PROVIDED. AS SUCH, THE EVENT WAS ASSESSED AS A NOT REPORTABLE MALFUNCTION SINCE THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON 12-DEC-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE SHAFT AND TIP WITH A WRINKLED TEXTURE, AND ELECTRODE LIFTED WITH EDGES. THESE FINDINGS WERE REVIEWED AND ASSESSED THE ISSUE OF DAMAGE ON THE ELECTRODE TO BE AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18441464 ↗
• MalfunctionJan 1, 2024Material Separation; Communication or Transmission Problem; Device-Device Incompatibility; Material Separation; Communication or Transmission Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTARNAV,10P,15MM DIA LOOP AND THE CATHETER FELL APART. IT WAS REPORTED THAT THE LASSOSTARNAV CATHETER FELL APART AND IS CURRENTLY STUCK INSIDE THE CRYO BALLOON. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423292 ↗
• MalfunctionDec 14, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSOSTAR NAV CIRCULAR MAPPING CATHETER AND THE LASSO WAS CAUGHT AND COULD NOT BE RELEASED FROM THE VALVE WITH SEVERAL MANEUVER ATTEMPTS. DURING AN AFIB PROCEDURE, AFTER INSERTING THE LASSO, THEY BEGAN MAPPING THE VEINS. AFTER WHICH THE LASSO APPROACHED TO THE MITRAL VALVE. THE MEDICAL PROFESSIONAL WANTED TO RETURN THE LASSO BACK INTO THE HELIOS BALLOON AND FELT THAT THE LASSO WAS CAUGHT AND COULD NOT BE RELEASED FROM THE VALVE. SEVERAL MANEUVER ATTEMPTS WERE MADE TO RELEASE BUT WITHOUT SUCCESS. IT WAS DECIDED TO INSERT A TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IN ORDER TO SEE WHAT IS HAPPENING INSIDE THE LEFT ATRIUM AND WITH THE HELP OF THE TEE AND ANOTHER MANEUVER WITH THE HELIOS BALLOON AND THE SHEATH, THE LASSO CATHETER WAS RELEASED FROM THE LEAFLET OF THE MITRAL VALVE AND THE OPERATION ENDED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE AND NO DAMAGE TO THE CATHETER. THE CATHETER DID NOT GO INTO THE VENTRICLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325903 ↗
• 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 ↗

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