Class 2 Device Recall Apical Coring Knife, HeartMate 3 LVAS Implant Kit

• Date Initiated by Firm: August 07, 2023
• Date Posted: September 29, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2658-2023
• Recall Event ID: 92951
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & HeartMate II Apical Coring Knife, REF: 1050
• Code Information: REF/UDI-DI/Serial Numbers: 106524US/00813024013297/MLP-034137 to MLP-034744, MLP-035485 to MLP-035714, MLP-036330 to MLP-037708, MLP-038104 to MLP-038999, MLP-039000 to MLP-039999, MLP-040000 to MLP-040999, MLP-041000 to MLP-041621; 106524INT/00813024011712 (OUS)/MLP-032482, MLP-035542 to MLP-035667, MLP-037218 to MLP-037527, MLP-038008 to MLP-038989, MLP-039014 to MLP-039945, MLP-040009 to MLP-040896, MLP-041013 to MLP-041589; 1050/00813024010227: 135021-135025, 134241-134246, 134248, 134250, 134251, 134240, 135060, 135061, 135062, 134247, 132849-132853, 134239; Apical Coring Knife Distributed Separately Serial Number Range: 132849 to 135062
• Recalling Firm/ Manufacturer: Thoratec Corp.; 6035 Stoneridge Dr; Pleasanton CA 94588-3270
• For Additional Information Contact: Shelley Lange; 612-346-3514
• Manufacturer Reason for Recall: Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist System, could result in an extended procedure or surgical time while the backup coring knife is acquired.
• FDA Determined Cause: Process control
• Action: On 8/7/23 customers were notified of the recall verbally, via email, in person visits, and phone calls. 8/21/23 the Abbott sales representatives started hand delivering correction notices to customers were told the firm was reinforcing the following warning in the Instructions for Use: 1) During the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in the event of an emergency. 2) Additionally, if unusual resistance is encountered during the coring procedure, immediately stop coring and complete using the backup Apical Coring Knife. Customers were also informed that in cases were the recall issue occurred during use, the physician was able to complete the procedure by using an Apical Coring Knife from the backup LVAS implant kit or an alternate surgical tool. Distribute this notice to those who need to be aware within your institution. Firm is continuing its investigation on this matter and working diligently to resume normal supply. Direct questions to your local Abbott representative. Complete and return the acknowledgement form via email to MCSHMNotices@Abbott.com Correction notices are continuing to be distributed identifying additional affected serial numbers. The firm is continuing to work with the apical coring knife vendor to supply knives that do not present this issue. However, the supply of unaffected apical coring knives continues to be limited.
• Quantity in Commerce: 2,681
• Distribution: Worldwide - US Nationwide distribution including in the states of 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 the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia , Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, 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.