FDA Device recall Z-0003-2016
SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters
- FDA Device
- Class II
- terminated
- Published 2015-10-07
On 2015-10-07 the FDA classified a Class II recall of SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters by Biosense Webster, citing 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 C….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0003-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-10 |
| Published | 2015-10-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biosense Webster |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Catalog #: 10439236, 10439072, 10439011, 10438577 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0003-2016%22
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