CLASS II Device recall · Reported 7 Oct 2015 · FDA Enforcement Report

Carto 3 EP Navigation System recalled by Biosense Webster

Biosense Webster is recalling Carto 3 EP Navigation System, distributed nationwide in the US. The recall was initiated on 10 Sep 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog #: C3SOUND, 10439236, 10439072, 10439011, 10438577

Quantity recalled1035 (U.S.)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0002-2016
FDA event ID: 72167
Recalling firm: Biosense Webster, Irwindale, CA
Classification: Class II
Status: Terminated
Recall initiated: 10 Sep 2015
FDA classified: 1 Oct 2015
Reported: 7 Oct 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Sep 2015	Recall initiated by company
1 Oct 2015	Classified by FDA	+21 days
7 Oct 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Is Carto 3 EP Navigation System recalled?

Yes. Biosense Webster recalled Carto 3 EP Navigation System on 10 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0002-2016.

Why was it recalled?

Which lots are affected?

Catalog #: C3SOUND, 10439236, 10439072, 10439011, 10438577

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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