Biosense Webster, Inc. recalls SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac…

Recall date

September 10, 2015

Source

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

Recall number

Z-0003-2016

FDA classification

Class II

Brand / firm

Biosense Webster, Inc.

Sold / distributed

Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.

Why it was recalled

Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.

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

What was recalled

SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.