Lasso D7L1015RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835000283), received between Nov 20, 2018 and Mar 4, 2022 — classified as 1 injury, 1 malfunction.

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

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. 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.

• InjuryMar 4, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A LASSO¿ ELECTROPHYSIOLOGY CATHETER. THE PATIENT SUFFERED CARDIAC TAMPONADE (CT) REQUIRING PERICARDIOCENTESIS AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT A BB (TRANSEPTAL PUNCTURE) AND LEFT ATRIAL ANGIOGRAPHY (LAG) WERE CONDUCTED. THE LASSO AND PENTARAY WERE PLACED TO THE LEFT ATRIUM (LA). THE PATIENT WAS IN ATRIAL FIBRILLATION ON THE ECG MONITOR AND BLOOD PRESSURE WAS LOW. THE PATIENT WAS CHECKED FOR A PERICARDIAL EFFUSION WHICH WAS CONFIRMED WHEN CHEST WALL ECHO WAS PERFORMED. PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT LEFT THE ROOM AT THAT TIME THE PERICARDIAL EFFUSION WAS MINIMAL ON ECHOCARDIOGRAPHY. ABLATION WAS NEVER PERFORMED AS THE CARDIAC TAMPONADE OCCURRED DURING THE MAPPING PHASE. THE PATIENT WAS UNDER OBSERVATION. THE PHYSICIAN COMMENTED THAT THERE WAS NO PROBLEM WITH THE PRODUCT. THE SHEATHS USED IN THE CASE WERE TWO SL0 AND ONE AGILIS SMALL 5FR SHORT SHEATH. THE TRANSEPTAL PUNCTURE WAS PERFORMED WITH A RF NEEDLE LARGE CURVE C1. PERSISTENT LEFT SUPERIOR VENA CAVA (PLSVC) WAS CHECKED ON THE CT, THERE WAS NO PROBLEM WI

  Patient problems: Cardiac Tamponade

  MAUDE report 13666549 ↗
• MalfunctionNov 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A LASSO¿ ELECTROPHYSIOLOGY CATHETER AND A TIP INSULATION PEELED OFF ISSUE OCCURRED. DURING THE PROCEDURE, WHEN PULLING BACK THE LASSO CATHETER INTO THE SHEATH, THE CATHETER TIP INSULATION (COATING) PEELED OFF. THE DAMAGE RESULTED IN INTERNAL COMPONENTS BEING EXPOSED. THERE WAS DIFFICULTY IN REMOVING THE CATHETER. TIP DETACHMENT DID NOT OCCUR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE TIP INSULATION PEELED OFF ISSUE HAS BEEN ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8093338 ↗

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-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
• 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