Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is intended for multiple electrode electrophysiological mapping of cardiac structures in the heart, ie., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The Pentaray NAV High-Density Mapping Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.

The firm, Biosense Webster, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/14/2016 to its customers. The letter described the product, problem and actions to be taken. The letter informs customers that the recall action is NOT a product removal, and that they may continue to use PENTARAY Catheters in accordance with the updated contraindication as stated in the recall letter. Customers are instructed to read and follow the Labeling Correction Notice carefully; pass on this letter to anyone in your facility that needs to be informed; maintain a copy of this letter with the PENTARAY Catheters, and sign and return the attached ACKNOWLEDGEMENT FORM immediately by email: [email protected], fax: 909-839-8514 or mail: Biosense Webster, Inc., Attn: FCA Coordinator,15715 Arrow Highway, Irwindale, CA 91706. The updated the IFU to clarify the contraindication statement as follows: "Do not use PENTARAY Catheters in patients with prosthetic valves". For questions related to this medical device correction, please contact your BWI sales representative or call 909-839-8500.