CLASS II Device recall · Reported 26 Feb 2014 · FDA Enforcement Report
CartoUnivu Module recalled by Biosense Webster
Biosense Webster is recalling CartoUnivu Module, distributed nationwide in the US. The recall was initiated on 12 Feb 2014 and the FDA has classified it as Class II.
Check your package
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-1045-2014
- FDA event ID
- 67505
- Recalling firm
- Biosense Webster, Irwindale, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2014
- FDA classified
- 20 Feb 2014
- Reported
- 26 Feb 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 12 Feb 2014 | Recall initiated by company | |
| 20 Feb 2014 | Classified by FDA | +8 days |
| 26 Feb 2014 | 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
Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.
Where it was distributed
Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.
Questions about this recall
Is CartoUnivu Module recalled?
Yes. Biosense Webster recalled CartoUnivu Module on 12 Feb 2014. The recall is Class II and its status is Terminated. Recall number Z-1045-2014.
Why was it recalled?
Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.
Which lots are affected?
Serial No. 13201, 11125, 11519, 11320, 11115.
Where was it sold?
Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.
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.
More recalls from Biosense Webster
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|---|---|---|---|---|---|
| Device | CLASS I | Varipulse Bi-Directional Ablation Catheter recalled by Biosense Webster | Biosense Webster | Other | 10 states |
| Device | CLASS II | Carto Vizigo Bi-Directional Guiding Sheath recalled by Biosense Webster | Biosense Webster | Other | Nationwide |
| Device | CLASS II | Carto Vizigo Bi-Directional Guiding Sheath, 5F(Medium) recalled | Biosense Webster | Labeling Errors | Nationwide |
| Device | CLASS II | Carto Vizigo Bi-Directional Guiding Sheath, 5F(Small) recalled | Biosense Webster | Labeling Errors | Nationwide |
| Device | CLASS II | Carto Vizigo 5F Bi-Directional Guiding Sheath recalled | Biosense Webster | Sterility | Nationwide |
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| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |