FDA-Device2015-10-07Class IIPROCESSING DEFECT

Biosense Webster SOUNDSTAR eco catheters recalled for image loss during system restart

OTHERNationwide distribution

Contact your cardiologist about SOUNDSTAR eco catheters

The SOUNDSTAR eco 8F and 10F ultrasound catheters used with the CARTO 3 EP Navigation System can lose their ultrasound image display when the system restarts during certain cardiac procedures, particularly when a patient has fluid around the heart (pericardial effusion). This image loss could affect the doctor's ability to see the heart during the procedure.

If your hospital or clinic uses these catheters, notify your cardiologist or electrophysiologist immediately
Do not use affected catheters until your medical team has reviewed the FDA safety precautions
Contact Biosense Webster at your facility's medical device representative for updated safety instructions

Hazard

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.

Sold states

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.

Affected count

1035 (U.S.)

Manufactured in

15715 Arrow Hwy, N/A, Irwindale, CA, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0003-2016

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