Class 2 Device Recall Navitor Titan

• Date Initiated by Firm: October 17, 2024
• Date Posted: November 20, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0491-2025
• Recall Event ID: 95627
• PMA Number: P190023
• Product Classification: Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
• Product: Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
• Code Information: UDI-DI (GTIN): 05415067045768, Serial Numbers: 20078589, 20357219, 20357226, 20357685, 20358319, 20358343, 20358351, 20358363, 20358368, & 20358370.
• Recalling Firm/ Manufacturer: Abbott Medical; 177 E County Road B; Saint Paul MN 55117
• For Additional Information Contact: Cynthia Kong,; 408-845-0883
• Manufacturer Reason for Recall: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
• FDA Determined Cause: Under Investigation by firm
• Action: A Medical Device Recall letter was hand delivered Oct. 21, 2024 to the one US consignee for 1 Impacted Valve. Nine foreign consignees were also notified for 26 Impacted Valves distributed outside of the United States (OUS). Customers are advised to return any remaining unused Impacted Valves, if applicable, and complete and return the accompanying Acknowledgement Form to Abbott. Abbott is executing further testing to verify that long-term durability of the Impacted Valves has not been affected and will communicate any changes to the recommendations set forth in this letter if needed by Q4 2025. In the interim, Abbott recommends continuing the same local standard of care in patients implanted with the Impacted Valve as would be used with patients implanted with any other transcatheter aortic valve implant. If you have any questions, please contact your local Sales Representative or Abbott Support at 1-800-544-1664 (Option 2).
• Quantity in Commerce: 1 US, 9 OUS
• Distribution: New York, Australia, Belgium, Germany, Iran, Israel, Japan, Kazakhstan, Oman, Poland, Romania, Slovakia, Spain, Turkey, United Kingdom.
• 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.

• PMA Database: PMAs with Product Code = NPT