We use cookies for Google Analytics and session tracking for your secure shopping experience. This is a single-use device. Note: If you need help accessing information in different file formats, see PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. Enjoy higher signal resolution using this navigational diagnostic catheter with five soft, flexible branches for better coverage. Instructions for Downloading Viewers and Players. The letter provides important information about the affected products and instructions on how the customers can return the affected products to Biosense Webster. Read more information on this website's Privacy Policy. CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY, Special Storage Condition, Specify: Do not use open or damaged packages, Special Storage Condition, Specify: Store in a cool dry place.

D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. Instructions for Downloading Viewers and Players, Class 2 Device Recall PENTARAY NAV Catheter and PENTARAY NAV ECO Catheter. This website also uses Open Source Software (OSS) provided by LiveChat to provide customer support. Experience an enhanced level of mapping detail across all four chambers with the PENTARAY®Catheter. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide.

Biosense Webster, Inc. is a global leader in the science of diagnosing and treating heart rhythm disorders.

Biosense Webster expanded the recall on 5/1/14 by sending a customer notification letter to all customers on 5/2/14 to include all product lots of the Pentaray Nav Catheter (Catalog No: D128201, D128202, D128204, Biosense Webster is expanding the recall on 5/1/14 to include all lots of the PentaRay Nav Catheter and the PentaRay Nav ECO Catheter because they can lead to an insufficient bond of the distal tip to the catheter shaft. In Stock!
Sign in to add this product to your favorites! D128205, D128207, D128208, D128210, D128211). As part of the Biosense Webster policy of continuous product development we reserve the right to change product specifications without prior notification. PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No.

As part of the Biosense Webster policy of continuous product development we reserve the right to change product specifications without prior notification. Load Time 0.06 seconds • System time 2020-10-15 02:09:28, 1-mm electrodes deliver high signal resolution, Accurate visualization of electrode position with the CARTO® 3 System, Five soft, flexible 3F branches ensure atraumatic contact with endocardium, Unique star shape provides full coverage, high density map. $999.00 box of 1 - Biosense Webster # D128208 - Biosense Webster Carto PentaRay Eco High Density Mapping Catheter The letter describes the product, the problems identified and the actions to be taken. Reproduced with Permission from the GMDN Agency. As part of the Biosense Webster policy of continuous product development we reserve the right to change product specifications without prior notification. Brand Name: PENTARAY NAV Version or Model: D128208 Commercial Distribution Status: In Commercial Distribution Catalog Number: D128208 Company Name: BIOSENSE WEBSTER INC. * Customers with questions related to the information provided in the customer notification, are instructed to contact their Biosense Webster sales representative or call (866)473-7823, Monday through Friday from 7am to 8pm EST. Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use. Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use. 510(K)s with Product Code = MTD and Original Applicant = BIOSENSE WEBSTER, INC. The customers were instructed to read the "Description of the Problem" section carefully; immediately identify and set aside all affected lots; maintain a copy of this letter with the affected PentaRay NAV Catheters until all units are returned to Biosense Webster; complete and return the Voluntary Field Removal Certification form via mail to: Biosense Webster, Inc., Attn: Field Action Coordinator, 15715 Arrow Highway, Irwindale, CA 91706, Fax to: 909-839-8514 or email to: rkazmi@its.jnj.com; arrange for return of all affected units you may have in your inventory; pass on this notice to anyone in your facility that needs to be informed, and if any of the affected product have been forwarded to another facility, contact that facility and arrange for the return. A sterile, steerable, flexible tube containing multiple electrodes that is introduced percutaneously into the heart chambers in order to transmit electrical impulses for electrophysiological diagnostic examinations, e.g., intracardiac sensing, endocardial recording, stimulation, temporary pacing for evaluation of cardiac arrhythmias, cardioversion (CV) of electrical arrhythmias or electrophysiology (EP) mapping of cardiac structures. Ships Today! It is typically made of plastic with embedded electrodes often of platinum (Pt), iridium, or a composite.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, Catheter,intracardiac mapping,high-density array, Code of Federal Regulations (CFR) Title 21 §7.55. 47 Biosense Webster jobs available on Indeed.com. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. Biosense Webster, Inc. is part of the Johnson & Johnson Family of Companies. Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Apply to Cardiology Physician, Biostatistician, Technician and more! The firm, Biosense Webster, sent an "URGENT FIELD SAFETY NOTICE MEDICAL DEVICE-VOLUNTARY FIELD RECALL (REMOVAL)" letter dated February 18, 2014 to all customers who purchased the PentaRay Nav Catheter. Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use. Customers with questions related to the Acknowledgement form and its return, are instructed to contact the Field Action Coordinator at (909) 839-8468. GMDN Names and Definitions: © Copyright GMDN Agency 2015. Labeling does not contain MRI Safety Information, Cardiac mapping catheter, percutaneous, single-use.

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