Class 2 Device Recall Carto Vizigo BiDirectional Guiding Sheath

• Date Initiated by Firm: February 21, 2023
• Date Posted: April 01, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1320-2023
• Recall Event ID: 91797
• 510(K)Number: K170997
• Product Classification: Introducer, catheter - Product Code DYB
• Product: Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath, 8.5F(Medium), REF D-1385-02-S, RX CE 2797, Sterile
• Code Information: Lot # 50000224; UDI (GTIN) : 10846835016277
• FEI Number: 3013300026
• Recalling Firm/ Manufacturer: Biosense Webster, Inc. ; 31 Technology Dr Ste 200; Irvine CA 92618-2302
• For Additional Information Contact: Maria Jose Arana; 619-565-7045
• Manufacturer Reason for Recall: Incorrect labeling; specifically, the product name, lot number and product code on the carton label for Bi-Directional Guiding Sheaths does not match the inner label pouch
• FDA Determined Cause: Under Investigation by firm
• Action: On March 2, 2023, Biosense Webster, Inc. issued an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" notification to affected US customers via FedEx. The notification was issued to foreign consignees on February 29, 2023. In addition to informing consignees about the recall Biosense Webster asked customer to take the following actions: 1. Carefully review the information contained in this Medical Device Correction/Removal. 2. Ensure that anyone in your facility who needs to be aware of this notification reads the attached letter carefully. 3. Evaluate if you have inventory of CARTO VIZIGO" Bi-Directional Guiding Sheath (Catalog Numbers: D-1385-01-S and D-1385-02-S) Lot Numbers 00002137 and 50000224 and segregate the product. For assistance in identifying impacted product, please reference ATTACHMENT 1: PRODUCT IDENTIFICATION TOOL. 4. Complete all fields of the attached Business Response Form. Please make sure to include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. 5. If you have inventory affected by this action: 5.1. Return inventory to Sedgwick using the enclosed return label. 5.2. Complete and sign the Business Response Form 5.3. Scan the signed completed form and email it to: BWI7774@sedgwick.com or Fax it to 888-877-7241. Subject: Attention: BWI Field Action Event #7774 6. If any of the affected products have been forwarded to another facility, contact that facility, and provide a copy of this to the relevant personnel. 7. Maintain a copy of this communication where the product identified in this letter is located until all products have been destroyed.
• Quantity in Commerce: 316 units
• Distribution: Worldwide distribution - US Nationwide distribution including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WI. The country of Japan.
• 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