Lasso D7L102515RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10846835000306), received between May 4, 2018 and Apr 10, 2020 — classified as 2 injuries, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K031161); 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.

• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING MEDICATION. WHILE MAPPING THE ATRIUM WITH THE ABLATION CATHETER, A PERICARDIAL EFFUSION OCCURRED. NO EXCESSIVE CONTACT FORCE WAS NOTED. AN ECHO EXAM WAS PERFORMED WHICH REVEALED A PERICARDIAL EFFUSION. NO DRAIN WAS PLACED AND ONLY MEDICATION WAS ADMINISTERED TO STABILIZE THE PATIENT. PROCEDURE WAS STOPPED. NO ADDITIONAL PATIENT ADVERSE EVENT. SINCE INTERVENTION WAS REQUIRED TO STABILIZE THE PATIENT AND THE PROCEDURE WAS ABORTED THIS EVENT WILL BE CONSERVATIVELY REPORTED UNDER THE LASSO CATHETER.

  Patient problems: Cardiac Tamponade

  MAUDE report 9947518 ↗
• MalfunctionJul 31, 2019Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER THAT HAD A ELECTRODE DAMAGE. IT WAS REPORTED THAT ELECTRODE 2 OF THE CATHETER SHOWED A MECHANICAL DAMAGE. THE LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER WAS REPLACED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. IT WAS LATER CLARIFIED THAT ELECTRODE 2 SEEMS TO BE PULLED OUT A LITTLE. THE ISSUE OF ELECTRODE DAMAGE HAS BEEN ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849147 ↗
• InjuryMay 4, 2018Entrapment of Device; Material Frayed; Knotted; Device Operational Issue; Entrapment of Device; Material Frayed; Knotted; Device Operational Issue

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A LASSO¿ 2515 VARIABLE CIRCULAR MAPPING CATHETER AND SUFFERED A MEDICAL DEVICE ENTRAPMENT REQUIRING SURGICAL INTERVENTION. AT THE BEGINNING OF THE PROCEDURE, PRIOR TO ABLATION, THE LASSO CATHETER BECAME ENTRAPPED DEEP IN THE LEFT ATRIAL APPENDAGE (LAA). IN AN ATTEMPT TO FREE THE LASSO CATHETER, THE DEVICE WAS ROTATED, RESULTING IN FURTHER ENTANGLEMENT. SHEATH WAS ADVANCED OVER THE LASSO CATHETER IN AN ATTEMPT TO RETRIEVE IT. AT THIS POINT, THE LASSO LOOP STRETCHED AND WAS RELEASED FROM THE LAA. PROCEDURE CONTINUED. UPON MANEUVERING TO THE RIGHT PULMONARY VEINS, THE LASSO LOOP BECAME ENTRAPPED IN THE SEPTUM. WHEN THE PHYSICIAN ATTEMPTED TO MANEUVER THE LASSO CATHETER THROUGH THE SEPTUM, THE LOOP FORMED A KNOT. IT WAS THEN DETERMINED THAT THE LOOP WAS DAMAGED AND THE MECHANISM WAS NOT FUNCTIONING PROPERLY. PHYSICIAN ATTEMPTED TO RETRIEVE THE LASSO CATHETER VIA SNARE WITHOUT SUCCESS. PHYSICIAN ATTEMPTED TO MANEUVER THE SHEATH OVER THE KNOTTED TIP WITHOUT SUCCESS. SUBSEQUENTLY, THE LASSO CATHETER WAS FORCEFULLY PULLED FROM THE LEFT ATRIUM INTO THE RIGHT

  Patient problems: Not Applicable

  MAUDE report 7489129 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031161. One submission often covers many models, so check the product and lot details in each record.

• Z-1703-2008 · Mar 25, 2008 · Terminated
  Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardi
• Z-1704-2008 · Mar 25, 2008 · Terminated
  Circular Mapping Catheter-Biosense Webster LASSO 2515 Variable Circular Mapping Catheter- The catheter is indicated for multiple electrode electrophysiological mapping of the cardi