Class 1 Device Recall Thoratec HeartMate 3, LVAS Implant Kit

• Date Initiated by Firm: March 01, 2024
• Date Posted: May 01, 2024
• Recall Status: Open, Classified
• Recall Number: Z-1692-2024
• Recall Event ID: 94232
• PMA Number: P160054
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly
• Code Information: UDI: 00813024013297/Serial Number: MLP-026628 MLP-026733 MLP-026929 MLP-027005 MLP-027322 MLP-027363 MLP-027387 MLP-027390 MLP-027596 MLP-027678 MLP-027879 MLP-028290 MLP-028518 MLP-028665 MLP-028754 MLP-028931 MLP-029026 MLP-029108 MLP-029187 MLP-029304 MLP-029368 MLP-029462 MLP-029473 MLP-029656 MLP-029682 MLP-029686 MLP-029845 MLP-030174 MLP-030180 MLP-030215 MLP-030216 MLP-030844 MLP-030945 MLP-030993 MLP-031350 MLP-031430 MLP-031507 MLP-031529 MLP-031710 MLP-031725 MLP-031780 MLP-032045 MLP-032092 MLP-032194 MLP-032302 MLP-032534 MLP-032794 MLP-032917 MLP-032926 MLP-032952 MLP-033026 MLP-033232 MLP-033394 MLP-033541 MLP-033633 MLP-033799 MLP-033829 MLP-033875 MLP-033905 MLP-033948 MLP-033960 MLP-033981 MLP-034050 MLP-034055 MLP-034059 MLP-034089 MLP-034090 MLP-034098 MLP-034135 MLP-034144 MLP-034184 MLP-034266 MLP-034380 MLP-034582 MLP-034594 MLP-034719 MLP-034721 MLP-034724 MLP-034816 MLP-034821 MLP-034835 MLP-034877 MLP-034879 MLP-034883 MLP-034926 MLP-035031 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• Recalling Firm/ Manufacturer: Thoratec Corp.; 6035 Stoneridge Dr; Pleasanton CA 94588-3270
• For Additional Information Contact: Ms. Shelley Lange; 612-346-3514
• Manufacturer Reason for Recall: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
• FDA Determined Cause: Device Design
• Action: On March 20, 2024, Abbott issued a Urgent: Medical Device Correction Notification to affected consignee via E-Mail. Abbott asked consignees to take the following actions: 1. The product is not being removed from the field and unused product does not need to be returned. 2. If blood leak or air entrainment is suspected or observed, follow standard surgical processes and the existing IFU: 2a. Residual air must be completely evacuated from the device blood chamber prior to initiating the LVAD support. 2b.Ensure that bleeding is assessed and ensure proper management of hemostasis before closing all wounds. 2c. Use conventional strategies for resolving air leaks or surgical bleeding, including: adjusting the pump position, waiting for the natural tendency of blood to coagulate or upon reversal of anticoagulation, adding surgical materials, and exchanging the apical cuff, the pump, or both. 2d. Always have a complete backup system (implant kit and external components) available on-site and in close proximity during the implantation procedure for use in the event of an emergency. 3. Please distribute this notice to those who need to be aware within your institution and complete the attached acknowledgment form included with this letter and return it to Abbott at email: MCSHMNotices@abbott.com. Should you have any questions about this communication, please contact your local Abbott representative or call 612-346-3514.
• Quantity in Commerce: 882 units
• Distribution: Worldwide Distribution: US (nationwide): AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, & WV; and OUS (foreign) countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, Colombia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, UK, United Arab Emirates, and Uzbekistan.
• 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 = DSQ and Original Applicant = Abbott Medical