LASSO NAV DLN1215CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835006780), received between Sep 13, 2017 and Aug 15, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2018Entrapment of Device; Mechanical Jam; Entrapment of Device; Mechanical Jam

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH A LASSO® NAV CATHETER AND SUFFERED A CARDIAC VALVE RUPTURE REQUIRING SURGICAL INTERVENTION. AT AN UNKNOWN PHASE OF THE PROCEDURE, WHILE A LASSO® NAV CATHETER WAS USED, ONE OF THE CATHETER ELECTRODES TWISTED THE CHORDAE TENDINEAE. A CARDIAC VALVE RUPTURE OCCURRED, AND A THORACIC SURGERY WAS REQUIRED. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED AS A RESULT OF THE ADVERSE EVENT. THERE¿S NO INFORMATION REGARDING PATIENT¿S OUTCOME OR PHYSICIAN¿S CAUSALITY OPINION. POST-PROCEDURE, THE PATIENT STILL FEELS A DULL PAIN IN THE CHEST THAT PREVENTS HIM FROM DOING HIS NORMAL DAILY ACTIVITIES, HE MUST STAY RESTING AT HOME. THE DISEASE HAS NOT BEEN CURED, RECURRENT OCCASIONALLY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY.

  Patient problems: No Code Available; Rupture

  MAUDE report 7786533 ↗
• MalfunctionFeb 6, 2018Hole In Material; Device Issue; Hole In Material; Device Issue

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A LASSO® NAV CATHETER. INITIALLY, IT WAS REPORTED THAT THE DEFLECTION WAS INADEQUATE DURING THE PROCEDURE AS THE CATHETER COULD NOT DEFLECT. THE CATHETER WAS EXCHANGED. NO PATIENT CONSEQUENCES WERE REPORTED. THIS EVENT WAS ASSESSED AS NOT REPORTABLE AS THE CATHETER WAS UNABLE TO DEFLECT, THE USER WILL NOT BE ABLE TO USE THE DEVICE AND WILL HAVE TO REPLACE IT. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH WAS REMOTE. THE BIOSENSE FAILURE ANALYSIS LAB RECEIVED THE CATHETER FOR ANALYSIS AND DISCOVERED DURING THE ASSESSMENT ON JANUARY 24, 2018 THAT THE TIP OF CATHETER WAS RECEIVED BROKEN AT 117.5 CM FROM THE HANDLE AND INTERNAL PARTS WERE EXPOSED. THIS RETURNED CATHETER CONDITION WAS ASSESSED AS A REPORTABLE MALFUNCTION. THEREFORE, THE AWARENESS DATE FOR THIS ISSUE IS JANUARY 24, 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246526 ↗
• MalfunctionSep 13, 2017Break; Unable to Obtain Readings; Break; Unable to Obtain Readings

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO® NAV CATHETER AND AN ELECTRODE WAS BROKEN. DURING THE PROCEDURE, THE MAP POINTS COULD NOT BE ACQUIRED. THEREFORE, THE CATHETER WAS WITHDRAWN FROM THE PATIENT AND THE PHYSICIAN FOUND THE 1ST ELECTRODE WAS BROKEN. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE CATHETER WAS CHANGED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THE INABILITY TO MAP IS NOT MDR REPORTABLE BECAUSE IF THE CATHETER CANNOT MAP BY THE CARTO SYSTEM, 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 IS REMOTE. HOWEVER, THE DAMAGED ELECTRODE IS MDR REPORTABLE BECAUSE IF THE ELECTRODE EDGES APPEAR TO BE SHARP OR ROUGH, THIS MAY CAUSE DAMAGE TO VASCULAR ENDOTHELIAL LININGS DURING THE WITHDRAWAL OF THE CATHETER AND SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6863554 ↗