SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMA

FDA device recall Z-1691-2015 · posted 2015-05-28 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

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.

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.

Root cause

Device Design

Status

Terminated

Product code

OAE

Quantity affected

115 units

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.

Date initiated

2015-03-19

Date posted

2015-05-28

Date terminated

2015-06-17

Location

Irwindale, CA