Biosense Webster Recalls SOUNDSTAR eco Diagnostic Ultrasound Catheters
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where the hazard is the loss of visualization during a critical cardiac event, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biosense Webster, Inc. is recalling 1,035 units of SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters in the United States. These catheters are used for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as for visualizing other devices in the heart. The recall affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with these specific catheters.
The recall was initiated because the ultrasound image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. The agency has classified this as a Class II recall. New precautions have been added to address this issue.
The affected products were distributed worldwide, including in the United States, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa. The specific catalog numbers involved are 10439236, 10439072, 10439011, and 10438577. Healthcare providers should contact Biosense Webster for further instructions on the new precautions and handling of these devices.
The recalled product
- Product
- 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.
- Manufacturer
- Biosense Webster, Inc.
- Affected units
- 1,035
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog #: 10439236
- 10439072
- 10439011
- 10438577
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Biosense Webster, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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