# P060040: Thoratec Heartmate II Left Ventricular Assist System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Apr 21, 2008 after 486 days
- Product code: DSQ (Ventricular (Assist) Bypass)
- Device class: 3
- Recalls of this device: 18 (12 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 9, 2025 · Class II · Z-0507-2026: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- Oct 9, 2025 · Class II · Z-0508-2026: Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
- Jun 23, 2025 · Class I · Z-2290-2025: 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.
- Jun 23, 2025 · Class I · Z-2291-2025: 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.
- Mar 13, 2025 · Class I · Z-1570-2025: Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to 
- May 8, 2024 · Class I · Z-1921-2024: System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, Distorted text, blanks, or zeroes in place of values, Unresponsive buttons where the user is unable to 
- Feb 19, 2024 · Class I · Z-1300-2024: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
- Mar 30, 2017 · Class I · Z-2053-2017: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related 
- Mar 30, 2017 · Class I · Z-2052-2017: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related 
- Mar 30, 2017 · Class I · Z-2051-2017: St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related 
- Mar 4, 2014 · Class I · Z-1230-2014: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller mode
- Mar 4, 2014 · Class I · Z-1228-2014: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller mode
- Mar 4, 2014 · Class I · Z-1227-2014: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller mode
- Mar 4, 2014 · Class I · Z-229-2014: Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller mode
- Feb 23, 2012 · Not classified · Z-1228-2012: A trend of disconnected bend reliefs on the sealed outflow graft used with the HeartMate II LVAS has been identified
- Sep 1, 2010 · Not classified · Z-0058-2011: Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection
- Oct 14, 2009 · Not classified · Z-0422-2010: Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some c
- Oct 24, 2008 · Not classified · Z-0496-2009: The firm has become aware that, over time, wear and fatigue of the percutaneous lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS) blood pump with external system controller 

Source page: https://510kreport.com/device/P060040
Methodology: https://510kreport.com/methodology