Consumer Alert: FDA Reports Recall of the BioSense Webster LASSO 2515 Variable Circular Mapping Catheter
February 4, 2009
Copyright 2009. All rights reserved. On September 3, 2008, the FDA issued an Enforcement Report that included a Class II Recall of the BioSense Webster LASSO 2515 Variable Circular Mapping Catheter.
According to the FDA report, the BioSense Webster LASSO Mapping Catheter "is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart . . . The device is designed to obtain electrograms in the Atrial regions of the heart."[1] The catheter is commonly used in cardiac ablation/pulmonary vein isolation procedures. According to the FDA enforcement report, "[t]his recall was initiated after the firm received several complaints reporting issues with deflection. The catheter may become caught in the mitral valve, requiring surgical procedures, valve may be torn while trying to dislodge, unable to retract the catheter through the sheath and require surgical intervention to remove, pulling on catheter to remove may lead to large atrial septal tear, and separation of the distal end of the catheter may occur. Also, the firm determined that when the catheter is fully deflected and the variable loop is fully contracted, it is possible that the catheter mechanism can become ‘locked' in position and cannot return to the un-contracted, un-deflected state. This could lead to damage to the device or limit the ability to withdraw the catheter safely."[2]
The results of catheter failure can be devastating, requiring surgery, lengthy hospitalization and difficult recovery.
Attorneys at Robins, Kaplan, Miller & Ciresi L.L.P. currently represent a patient injured by the BioSense Webster LASSO Mapping Catheter. If you or someone you know has been injured by the use of the BioSense Webster LASSO Mapping Catheter and you wish to consult with a lawyer, please call Dan O'Fallon at 612-349-8717 or Amy Hanf at 612-349-0917. You can also reach us toll-free at 1-800-553-9910.
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