Class 2 Device Recall HeartMate 3 Coring Tool

• Date Initiated by Firm: March 01, 2019
• Date Posted: April 19, 2019
• Recall Status: Terminated on August 10, 2022
• Recall Number: Z-1203-2019
• Recall Event ID: 82458
• PMA Number: P160054S005
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.
• Code Information: Lot Numbers: 6675594 6675724 6675730 6677921 6696569 6696580 6696582 6696597 6696601 6696604 6703553 6703561 6703563 6703567 6721603 6721660 6721661 6721663 6721671 6721672 6721673 193496 193497 193499 193501 6425740 6425773 6449684 6675597 6449680 6425751 6425758 6425763 6425768 6449657 6449662 6512124 6677922 6425756 6425766 6425770 6449675 6449681 6449691 6675592 6677919 6677926 6694918 6696574 193500 193502 6425745 6425776 6449663 6449664 6449679 6449682 6449687 6449689 6677924 6677927 6692906 6693957 6696589 193495 193498 6449692 6675591 6675596 6692904 6696599 6512126 6675732 6675734 6675736 6692897 6449677 6692877
• Recalling Firm/ Manufacturer: Thoratec Corp.; 6035 Stoneridge Dr; Pleasanton CA 94588-3270
• For Additional Information Contact: Justin Paquette; 651-756-6293
• Manufacturer Reason for Recall: Small black plastic particle was observed in the left ventricle during implant procedure.
• FDA Determined Cause: Device Design
• Action: On 03/01/19, sales representatives started visiting and telephoning consignees informing them to quarantine affected devices. The firm requested that consignees complete and return the Device Retrieval Template. On 03/08/19, Urgent Medical Device Recall notices were hand delivered to all impacted accounts. Customers were advised to stop use, quarantine, and return any units on hand. For patients, who's implant procedure included the use of affected devices, firm recommends close vigilance for potential harm, which could include concerns such as infection or thromboembolism. The coring knife is not impacted. Firm requests that customers complete and return the acknowledgement form. Firm recommends that customer with additional questions call 1-800-456-1477.
• Quantity in Commerce: 650
• Distribution: US Nationwide distribution in the states of MN, WI, TX, NC, GA, OK, UT, NY, SC, IL, LA, MI, IN, CA, OH, WA. Foreign (OUS): AUSTRIA, BELGIUM, CANADA, ESTONIA, FRANCE, GERMANY, GREECE, INDIA, ITALY, KUWAIT, LIECHTENSTEIN, LITHUANIA, NETHERLANDS, POLAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, 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 = DSQ