Devices

Device Recall SMARTABLATE System

Model / Serial
Product Codes M490006, M490007
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Distributed to the following states: CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI. Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.
Product Description
SMARTABLATE RF System Generator
Manufacturer
Biosense Webster, Inc.
1 Event
- Recall of Device Recall SMARTABLATE System

Manufacturer

Biosense Webster, Inc.

Manufacturer Address
Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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