Class 2 Device Recall Abbott MitraClip XTR Clip Delivery System

• Date Initiated by Firm: May 01, 2019
• Create Date: May 29, 2019
• Recall Status: Terminated on December 11, 2020
• Recall Number: Z-1687-2019
• Recall Event ID: 82746
• PMA Number: P100009S025
• Product Classification: Mitral valve repair devices - Product Code NKM
• Product: Abbott MitraClip XTR Clip Delivery System, UDI: 08717648226366, Part: CDS0601-XTR, Sterile EO, Rx Only
• Code Information: All Serial Numbers.
• Recalling Firm/ Manufacturer: Abbott Vascular; 26531 Ynez Rd; Temecula CA 92591-4630
• For Additional Information Contact: Mary Kokkinen; 408-845-0808 Ext. 0808
• Manufacturer Reason for Recall: Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.
• FDA Determined Cause: Use error
• Action: On 05/01/19, Urgent Medical Device Correction notices were sent to implanting physicians, via personal delivery or email, informing them that under normal use conditions, this failure will not occur. To prevent unintended force from being applied to the clip, revised instructions, including definition and related technique, for performing the steps "Establish Final Angle" and "Invert the Clip Arms" were developed and provided herein. The revised instructions will be applied to the shared XTR and NTR Clip Delivery System Instructions for Use. Unintended excessive force applied to the NTR Clip Delivery System during "Establish Final Arm Angle" can result in unexpected movement of clip arms; however, unlike XTR, the NTR Clip does not become damaged and remains functional. Adhering to the revised IFU sections for both product platforms will ensure consistency of use. Further, the firm requested that customers read the Field Safety Notice, review revised instructions for use with firm representatives, sign and return Effectiveness Check Forms, and share this information with all personnel associated with the procedure. The revised instruction steps provided in this communication will be updated in the product IFU and included in associated training. Your current inventory of product is acceptable for safe use following the revised IFU steps described above. There is no need to return any product. Customers with additional questions are encouraged to call customer service at 800-227-9902.
• Distribution: U.S.: FL, UT, IN, OK, TX, CO, LA, AZ, MO, AL, GA, CA, AR, KS, IL, HI, IA, KY, MA, DC, NY, NV, NM, NJ, MT, MD, NC, CT, MI, MN, OH, ND, NH, OR, PA, WI, WA, VA, WV, TN, SC, RI, DE, ME, NE, SD, MS, ID, VT. Foreign (OUS): AUSTRALIA, AUSTRIA, BELGIUM, BULGARIA, Canada, CROATIA, CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, KUWAIT, LEBANON, MACAU, NETHERLANDS, NEW ZEALAND, NORWAY, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NKM