Class 2 Device Recall CARTO VIZIGO" BiDirectional Guiding Sheath

• Date Initiated by Firm: February 16, 2024
• Date Posted: March 13, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1290-2024
• Recall Event ID: 94014
• 510(K)Number: K170997
• Product Classification: Introducer, catheter - Product Code DYB
• Product: CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502; ; The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide accessibility and maneuverability in the cardiac anatomy. The steerable sheath is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A side port with a three-way stopcock is provided for air or blood aspiration, and fluid infusion. The handle is equipped with a rotating collar to deflect the tip clockwise = 180¿ and counterclockwise = 180¿. The steerable sheath features distal vent holes to facilitate aspiration and minimize cavitation, and a radiopaque tip marker to allow fluoroscopic visualization. The sheath has electrodes on the outer surface to allow the sheath to interface with compatible CARTO" 3 Systems.
• Code Information: Product No. D-1385-02 UDI-DI code: 10846835016277 Lot Numbers: 60000282 60000282
• Recalling Firm/ Manufacturer: Biosense Webster, Inc. ; 31 Technology Dr Ste 200; Irvine CA 92618-2302
• For Additional Information Contact: Maria Jose Arana; 908-904-5077
• Manufacturer Reason for Recall: Due to a manufacturing issue, device under process validation phase were inadvertently mixed into the main manufacturing process.
• FDA Determined Cause: Under Investigation by firm
• Action: On 02/16/2024, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via FedEx to customers informing them that Biosense Webster identified through a complaint investigation that a mix-up occurred during the manufacturing of two lots. The devices could potentially be shorter in length (24 1/8 inches (61.28 cm) instead of, 28 inches (71 cm). Customer are instructed/informed: If a CARTO VIZIGO" Bi-Directional Guiding Sheath, Medium Curve (Catalog Number: D-1385-02) from Lot Numbers 60000282 and 60000287 is being used in their facility, they should continue to follow the IFU. The Instructions for Use, on Page 7, instructs users to inspect all components before use, and prior to inserting the device into the patient, pre-assemble the sheath, dilator, and stylet on the table. While setting up for a procedure, if the dilator is protruding out the tip of the sheath more than 4 inches (10 cm), do not use the sheath. Destroy the device following their standard process. Please complete the Attestation of destruction form (Attachment 2) to receive a replacement and email it to: Email: OneMD-Field-Actions@its.jnj.com Subject: Attention: BWI Field Action Coordinator- Attestation product destruction. For questions or further assistance, contact Biosense Webster at OneMD-Field-Actions@its.jnj.com
• Quantity in Commerce: 853 units
• Distribution: U.S. Nationwide distribution including in the states of FL, IL, AL, NY, PA, SC, AZ, MI KY, NJ, WI, IN, LA, TX, MA, OH, AR, MT, MO, VA, NC, TN, CA, MN, WV, CT, CO, IA, MD, ID, NM, NH, UT, GA, WA, NV, OK, KS, AK, NE, HI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DYB and Original Applicant = Biosense Webster, Inc.