NA RD134301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551044790), received between Apr 5, 2023 and Jan 23, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE, WITH A REPROCESSED EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER AND DURING DEVICE ANALYSIS A MISSING ELECTRODE WAS DISCOVERED. DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO LEFT ATRIUM AND NOISE WAS OBSERVED ON LASSO POLES 17-18 ON BOTH THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM. ALL OTHER INTRACARDIAC AND BODY SURFACE ELECTROGRAM SIGNALS WERE CLEAR. THE CATHETER WAS UNPLUGGED AND RE-PLUGGED, HOWEVER, NOISE REMAINED ON LASSO POLES 17-18. THE CABLE WAS REPLACED, AND THE ERROR REMAINED. A DIFFERENT REPROCESSED LASSO CATHETER WAS USED, AND THE ERROR RESOLVED. THE PROCEDURE CONTINUED WITH NO ADVERSE EVENTS. THIS EVENT IS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO STERILMED FOR EVALUATION IN WHICH THE MISSING ELECTRODE WAS DISCOVERED. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18567376 ↗
• MalfunctionApr 5, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION PROCEDURE WITH AN EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER AND A CONTRACTION STUCK ISSUE OCCURRED. DURING THE PROCEDURE, THE EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER WAS INSERTED INTO LEFT ATRIUM. WHILE MANEUVERING THE CATHETER AND ATTEMPTING TO OPEN AND CLOSE THE EP CATHETER WEBSTER LASSO® 2515 ECO VARIABLE CATHETER LOOP TO CREATE THE LEFT ATRIAL ANATOMY, THE CATHETER WOULD CLICK WHEN CLOSING THE LOOP, CREATING RESISTANCE TO OPEN THE LOOP AGAIN. PHYSICIAN PULLED THE CATHETER OUT OF THE PATIENT AND INSPECTED THE CATHETER TO CONFIRM FAULTY MECHANISM. SINCE SOME OF THE LEFT ATRIAL ANATOMY WAS ALREADY CREATED, PHYSICIAN CONTINUED TO MAP USING THE ABLATION CATHETER. THE PROCEDURE CONTINUED WITH NO ADVERSE EVENT. THE PROCEDURE WAS NOT DELAYED. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A CONTRACTION STUCK ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16684974 ↗