Carto 3 EP Navigation System — Class II medical device recall Z-0002-2016
Terminated recall by Biosense Webster, Inc., reported 2015-10-07, distributed nationwide. Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting w
| Recall number | Z-0002-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biosense Webster, Inc., Irwindale, CA, United States |
| Recall initiated | 2015-09-10 |
| Classified | 2015-10-01 |
| Reported by FDA | 2015-10-07 |
| Terminated | 2016-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CN, CO, DE, ES, FI, FR, GB, HU, IE, IN, IT, JP, MX, NL, RU, SE, SG, SI, ZA |
| Quantity | 1,035 |
| Model numbers | 10438577, 10439011, 10439072, 10439236, C3SOUND |
Product
Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0002-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.