Lasso LN122515CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835008272), received between Dec 19, 2018 and Apr 1, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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.

• MalfunctionApr 1, 2024Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED A LASSO® 2515 NAV VARIABLE CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE DEVICE TIP TO BE KNOTTED. INITIALLY, IT WAS REPORTED THAT A SENSOR ERROR WAS OBSERVED. NO OTHER INFORMATION WAS PROVIDED, AND NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE SENSOR ERROR ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 06-MAR-2024, THE DEVICE TIP WAS OBSERVED KNOTTED. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 06-MAR-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015343 ↗
• MalfunctionMar 4, 2021Mechanical Jam; Positioning Problem; Unintended Movement; Mechanical Jam; Positioning Problem; Unintended Movement

  IT WAS REPORTED A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A LASSO¿ 2515 NAV VARIABLE CATHETER AND THE DEFLECTION MECHANISM BECAME STUCK. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT AT THE BEGINNING OF THE PROCEDURE CONTRACTION AND DEFLECTION ISSUES OCCURRED. IT WAS REPORTED THAT THE LASSO¿ 2515 NAV VARIABLE CATHETER LOST ITS LOOP CONTRACTION ABILITY AND COULDNT DEFLECT. THE CATHETER WAS EXCHANGED TO CONTINUE THE CASE SUCCESSFULLY. THERE WERE NO REPORTS OF PATIENT CONSEQUENCE. THE REPORTED LOSS OF LOOP CONTRACTION AND CATHETER DEFLECTION MECHANISM WERE CONSIDERED NOT MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH IS REMOTE. ON 1/14/2021, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. ON 2/8/2020, DURING PRODUCT EVALUATION, THE DEVICE WAS FOUND IN A FULLY DEFLECTED POSITION WITH ITS LOOP FULLY CONTRACTED. CATHETER FAILED DEFLECTION TEST SINCE IT CANNOT BE UNDEFLECTED AND UNCONTRACTED (STUCK). THESE FINDINGS WERE ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11412787 ↗
• MalfunctionFeb 12, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® 2515 NAV VARIABLE CATHETER AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) FOUND WHITE AND CLEAR MATERIAL ALL OVER THE SHAFT, LEADER TUBING, TWO SIDES OF THE BARREL, AND BLUE CLIP. INITIALLY, IT WAS REPORTED THAT DURING THE PROCEDURE, THE CATHETER COULD NOT DEFLECT. A SECOND CATHETER WAS USED TO COMPLETE THE OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED DEFLECTION 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 1/14/2020, THE BWI PAL RECEIVED THE DEVICE FOR EVALUATION. UPON INITIAL INSPECTION, NO DAMAGE OR ANOMALIES OBSERVED. FURTHER TESTING WAS THEN PERFORMED. DURING A SECOND VISUAL INSPECTION ON 1/15/2020, THE BWI PAL FOUND WHITE AND CLEAR MATERIAL ALL OVER THE SHAFT, LEADER TUBING, TWO SIDES OF THE BARREL, AND BLUE CLIP. THE OBSERVED FOREIGN MATERIAL HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION. THE AWARENESS DATE HAS BEEN RESET TO 1/15/2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9702282 ↗
• MalfunctionDec 19, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A LASSO® 2515 NAV VARIABLE CATHETER. THE VARIABLE LOOP OF THE CATHETER WAS NOT VARYING MAKING IT IMPOSSIBLE FOR THE PHYSICIAN TO CONTINUE THE PROCEDURE WITH THIS CATHETER. THE CATHETER WAS EXCHANGED AND THE PHYSICIAN CONTINUED THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS CONTRACTION ISSUE WAS ASSESSED AS NOT REPORTABLE. SINCE THE LOOP CONTRACTION MECHANISM WAS NOT WORKING PROPERLY, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE WEBSTER FAILURE ANALYSIS LAB RECEIVED THE CATHETER FOR EVALUATION AND ON DECEMBER 1, 2018 NOTED THE SPINE COVER WAS CUT OPEN IN SEVERAL PLACES WITH METAL EXPOSED AND REDDISH-BROWN MATERIAL INSIDE THE CUT AREAS. SOME WHITE STRESS MARKS ON THE PROXIMAL SIDE OF RING #10. THE SPINE COVER WAS WRINKLED DOWN ON THE POLYURETHANE (PU) MARGIN TO THE TRANSITION WITH PEEK HOUSING. THE SPINE COVER WAS TWISTED AND WRINKLED ON THE PROXIMAL OF RING #10. THE SPINE COVER CUT OPEN WITH METAL EXPOSED WAS ASSESSED AS A REPORTABLE ISSUE AS THE CATHETER INTEGRITY WAS COMPRO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8177653 ↗