PlainRecalls
FDA Devices Moderate Class II Terminated

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 SMARTABLA

Reported: June 3, 2015 Initiated: March 19, 2015 #Z-1691-2015

Product Description

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.

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.

Details

Recalling Firm
Biosense Webster, Inc.
Units 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.
Location
Irwindale, CA

Frequently Asked Questions

What product 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.. Recalled by Biosense Webster, Inc.. Units affected: 115 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2015. Severity: Moderate. Recall number: Z-1691-2015.

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