FDA (Devices) recall action 72167
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Biosense Webster is recalling the Carto 3 EP Navigation System because the ultrasound image may disappear during use, requiring a system restart.
Biosense Webster is recalling SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters because the ultrasound image may disappear if the CARTO 3 system restarts during a pericardial effusion.