Biosense Webster, Inc. recalls CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 a…

Recall date

August 15, 2016

Source

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

Recall number

Z-2776-2016

FDA classification

Class II

Brand / firm

Biosense Webster, Inc.

Sold / distributed

International Distribution to China, Hong Kong and Brazil.

Why it was recalled

Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).

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

What was recalled

CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.