HeartMate Power Unit (Thoratec) – Power Cord Locking (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while
Brand
Thoratec LLC
Lot Codes / Batch Numbers
Lot Code: US Model No 107760, UDI-DI 05415067038258, For Lot Numbers, see Attachment F.
Products Sold
Lot Code: US Model No 107760; UDI-DI 05415067038258, For Lot Numbers, see Attachment F.
Thoratec LLC is recalling Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 due to Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Pow. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Recommended Action
Per FDA guidance
Customer advisory letters dated June 23, 2025, will be hand delivered and by email to all impacted consignees. The customer advisory letters will be posted on the Abbott Product Advisory website for further visibility. As stated in the customer letter, affected AC Power Cords from US and OUS consignees and patient units that are experiencing connection issues will be returned and replaced. Instruction to Customers: Refer to "User Action Requested" section in attached customer letter for instructions to consignees. (Attachment D1, D2, and D3)
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026