Biosense Webster, Inc. recalls SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SM…

Recall date

March 19, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1691-2015

FDA classification

Class II

Brand / firm

Biosense Webster, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.