Lasso D7L1015CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835005806), received between Nov 19, 2020 and Nov 19, 2020 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K002333); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER AND A LASSO¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS AND SURGICAL INTERVENTION. AFTER THE TRANSSEPTAL PUNCTURE WITH AN ABBOT BRK1 TRANSSEPTAL NEEDLE, THE LASSO¿ ELECTROPHYSIOLOGY CATHETER WITH AUTO ID WAS POSITIONED IN THE LEFT ATRIUM (LA). THE PHYSICIAN PERFORMED AN ANGIOGRAPHY OF THE PULMONARY VEINS USING A MULTIPURPOSE SHEATH. WHILE MANIPULATING THE SHEATH IN THE LA, THE PATIENT BECAME HYPOTENSIVE AND CARDIAC TAMPONADE WAS CONFIRMED BY ECHOGRAPHY. PERICARDIOCENTESIS WAS PERFORMED TO DRAIN THE BLOOD FROM THE PERICARDIAL SPACE. AFTER A SHORT WHILE, THE PATIENT STABILIZED, AND THE PROCEDURE WAS CONTINUED. ABLATION WAS PERFORMED WITH A NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER. TOWARDS THE END OF THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED AGAIN, AND THE SITUATION GOT CRITICAL AND THE BLEEDING COULD NOT BE STOPPED ANYMORE, SO THE PATIENT WAS IMMEDIATE TRANSFERRED TO CARDIAC SURGERY ON WHICH AN ENDOCARDIAL INJURY AT THE BASE OF THE LEFT ATRIAL APPENDAGE (L

  Patient problems: Cardiac Tamponade; No Code Available

  MAUDE report 10867385 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002333. One submission often covers many models, so check the product and lot details in each record.

• Z-2667-2011 · May 23, 2011 · Terminated
  LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-1220-82-S, Catalog Numbers 07L2015CT The affected catheters are indicated for multiple electrod
• Z-2666-2011 · May 23, 2011 · Terminated
  LASSO Deflectable Circular Mapping Catheter with Auto 10 Technology, Part Numbers D-122081- S, Catalog Numbers D7L2020CT The affected catheters are indicated for multiple electrod