LASSO NAV D134902Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835009668), received between Oct 9, 2020 and Dec 16, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Entrapment of Device” (1 report).

1 other recall cover devices cleared under the same FDA submission (K113213); they may or may not involve this specific model.

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.

• InjuryDec 16, 2021Entrapment of Device; Patient Device Interaction Problem; Entrapment of Device; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE (B)(6) PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO® NAV ECO CATHETER AND THE LASSO CATHETER GOT CAUGHT IN THE MITRAL VALVE WHICH REQUIRED SURGICAL INTERVENTION. AFTER THE CATHETER WAS INSERTED INTO THE PATIENT¿S BODY, DURING MAPPING WAS CONDUCTED AT THE LEFT ATRIUM (LA), THE LASSO GOT CAUGHT IN THE MITRAL VALVE (MV) AND COULD NOT BE REMOVED. THORACOTOMY WAS PERFORMED WITHOUT OMISSION. AN EMERGENCY SURGERY WAS PERFORMED TO OPEN THE CHEST. THE PHYSICIAN COMMENTED THAT ALTHOUGH IT WAS NOT AN ARTIFICIAL VALVE, THE TIP SHAPE OF THE LASSO SLID TOWARD THE LEFT VENTRICLE DURING MAPPING OF THE LA FLOOR, WHERE IT WAS CAUGHT BY A STRUCTURE. THE OPEN-CHEST SURGERY ENDED UNEVENTFULLY. THE OPERATION DID NOT REQUIRE VALVE REPLACEMENT, AND THE PATIENT UNDERWENT AFIB TREATMENT AND LEFT ATRIAL APPENDAGE (LAA) CLOSURE WITH THE MAZE OPERATION. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND HAS RETURNED TO THE GENERAL WARD. THE CHEST OPENING OPERATION WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THIS ADVERSE EVENT IS THAT THIS IS PROCEDURE RELATED. THE PATIENT OUTCOME OF THE ADVERSE EVE

  Patient problems: Foreign Body In Patient; Unspecified Heart Problem

  MAUDE report 13015885 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED CARDIAC ABLATION PROCEDURE ON WHICH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND TWO LASSO® NAV ECO CATHETERS WERE USED FOR MAPPING, AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, TWO LASSO® NAV CATHETERS AND A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER WERE PLACED IN THE RIGHT ATRIUM (RA) FOR SEPTAL PUNCTURE. AFTERWARDS, THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND LASSO CATHETERS WERE PLACED IN THE LEFT ATRIUM (LA). LA GEOMETRY WAS CREATED WITH THE THREE CATHETERS. THE PHYSICIAN FELT ABNORMALITY WHILE USING THE CATHETERS. AFTER CREATING THE GEOMETRY, PERICARDIAL EFFUSION WAS CONFIRMED WITH THE SOUNDSTAR PLACED IN THE RA. REMAINDER OF THE PROCEDURE WAS ABORTED, AND PERICARDIOCENTESIS WAS PERFORMED TO DRAIN AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. EFFUSION DID NOT CONTINUE TO ACCUMULATE AFTER PERICARDIAL DRAINAGE. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED. PATIENT¿S OUTCOME IS UNKNOWN. THE PHYSICIAN COMMENTED IT IS UNKNOWN WHEN THE EVENT HAPPENED AND IF THERE WAS RELATIONSHIP WITH THE PRODUCTS. HE SAID HE WAS A LIT

  Patient problems: Cardiac Tamponade

  MAUDE report 10659399 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNSPECIFIED CARDIAC ABLATION PROCEDURE ON WHICH A THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND TWO LASSO® NAV ECO CATHETERS WERE USED FOR MAPPING, AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, TWO LASSO® NAV CATHETERS AND A SOUNDSTAR ECO 8FG ULTRASOUND CATHETER WERE PLACED IN THE RIGHT ATRIUM (RA) FOR SEPTAL PUNCTURE. AFTERWARDS, THE THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER AND LASSO CATHETERS WERE PLACED IN THE LEFT ATRIUM (LA). LA GEOMETRY WAS CREATED WITH THE THREE CATHETERS. THE PHYSICIAN FELT ABNORMALITY WHILE USING THE CATHETERS. AFTER CREATING THE GEOMETRY, PERICARDIAL EFFUSION WAS CONFIRMED WITH THE SOUNDSTAR PLACED IN THE RA. REMAINDER OF THE PROCEDURE WAS ABORTED, AND PERICARDIOCENTESIS WAS PERFORMED TO DRAIN AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE. EFFUSION DID NOT CONTINUE TO ACCUMULATE AFTER PERICARDIAL DRAINAGE. IT IS UNKNOWN IF EXTENDED HOSPITALIZATION WAS REQUIRED. PATIENT¿S OUTCOME IS UNKNOWN. THE PHYSICIAN COMMENTED IT IS UNKNOWN WHEN THE EVENT HAPPENED AND IF THERE WAS RELATIONSHIP WITH THE PRODUCTS. HE SAID HE WAS A LIT

  Patient problems: Cardiac Tamponade

  MAUDE report 10659395 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113213. One submission often covers many models, so check the product and lot details in each record.

• Z-1617-2013 · Jun 19, 2013 · Terminated
  20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.