SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.
- Company
- Biosense Webster, Inc.
- Recall Initiated
- March 19, 2015
- Posted
- May 28, 2015
- Terminated
- June 17, 2015
- Recall Number
- Z-1691-2015
- Quantity
- 115 units
- Firm Location
- Irwindale, CA
Reason for Recall
Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Generator inadvertently delivered RF energy.
Distribution
Worldwide Distribution - US Nationwide in the state of: CA, IL, KY, NJ, PA and the countries of: Czech Republic, Denmark, Finland, France, Germany, and Sweden.
Lot / Code Info
SMARTABLATE System Serial No. G4C-0296, G4C-0297, G4C-0272, G4C-0262, G4C-0232, G4C-0090. System Serial No. G4C-0076, G4C-0195, G4C-0064, G4C-0047, G4C-0159, G4C-0187, G4C-0146, G4C-0140, G4C-0037, G4C-0131, G4C-0031, G0054.
Root Cause
Device Design
Action Taken
Biosense Webster sent an Urgent Field Safety Notification Letter dated March 18, 2015 via FedEx to all their customers that received the affected SMARTABLATE Generator System. The letter informs the customers of the problems identified and the actions to be taken. Biosense Webster is taking precautionary safety measures of reinforcing the Warnings in the Instructions for Use (IFU) for the SMARTABLATE System Foot Pedal. Customers with questions related to the are instructed to contact their local Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7:00AM to 8:00PM EST. Customers with questions related to the voluntary field removal certification form and its return, are instructed to contact Elie Ghattas Field Action Coordinator at (909) 839-7281.