PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 7, 2015 Initiated: September 10, 2015 #Z-0003-2016

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Biosense Webster, Inc.
Units Affected
1035 (U.S.)
Distribution
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.
Location
Irwindale, CA

Frequently Asked Questions

What product 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.. Recalled by Biosense Webster, Inc.. Units affected: 1035 (U.S.).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 7, 2015. Severity: Moderate. Recall number: Z-0003-2016.

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