Z-0003-2016Class II

SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization...

Name: Z-0003-2016 SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization...
Creator: Biosense Webster, Inc.
Published: 2015-09-10
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2015-09-10 / Terminated / root cause: design

FDA source

Biosense Webster, Inc. began a recall of SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology... on 2015-09-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0003-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-10
Posted: 2015-10-01
Terminated: 2016-05-13
Recalling firm: Biosense Webster Inc
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.
Product code: OBJ Catheter, Ultrasound, Intravascular
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.
Root cause tag: design
FDA root cause: Device Design
Action: A Customer Notification Letter and Acknowledgement Form was distributed to customers on 09/10/15. One letter and form was sent via express mail, addressed to the Risk Management Office and one additional letter and form was sent by the firm's account representative to the Electrophysiology (EP/Cardiology Lab directly at the customer site. The firm's notification letter stated that they want to emphasize the following statement "The intra-cardiac ultrasound image will disappear if the CARTO 3 EP Navigation System power is disrupted and this may present a safety issue if the EP is using the ultrasound to monitor the patien during EP procedure. The ultrasound image will not reappear until the CARTO 3 System is restored." The firm will be updating the product labeling to further reinforce the precautionary statement. The firm requests that customers take the following actions: 1. Read the Field Safety Notification carefully. 2. Pass on this notification to anyone in the facility that needs to be informed of this issue, including appropriate clinical personnel involved in the use of SOUNDSTAR eco Catheters. 3. Review, complete, sign and return the attached Acknowledgement Form in accordance with the instructions on the form. 4. Maintain a copy of this letter with the product. 5. Maintain awareness of the Field Safety Notification For any questions the firm states to contact the BWI sales representative.
Quantity in commerce: 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.
Product codes and lots: Catalog #: 10439236, 10439072, 10439011, 10438577

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0003-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0002-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-07	2015-10-01
Z-0003-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-07	2015-10-01

Product code OBJ

K140318Class IISoundstar Eco 8F Gultrasound Catheter, Soundstar Eco 8F Ultrasound CatheterBiosense Webster / cleared 2014-03-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)