CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2369-2012.
The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2369-2012.
Recall terminated by FDA.
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- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2369-2012.
Biosense Webster, Inc.
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Biosense Webster, Inc. Recall FAQ
Biosense Webster, Inc. is the subject of a cardiac devices safety report: CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system .... The notice was published on November 17, 2009 by the U.S. Food and Drug Administration (FDA). Approximately 71 units are potentially affected.