# P160054: HeartMate 3™ Left Ventricular Assist System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Aug 23, 2017 after 261 days
- Product code: DSQ (Ventricular (Assist) Bypass)
- Device class: 3
- Recalls of this device: 18 (9 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
- May 13, 2026 · Class II · Z-2520-2026: Due to 11 volt Backup Battery failures.
- May 13, 2026 · Class II · Z-2519-2026: Due to 11 volt Backup Battery failures.
- May 13, 2026 · Class II · Z-2518-2026: Due to 11 volt Backup Battery failures.
- Oct 9, 2025 · Class II · Z-0505-2026: 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-0506-2026: 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 
- Jun 25, 2024 · Class II · Z-2583-2024: Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circu
- 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 
- Mar 1, 2024 · Class I · Z-1692-2024: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
- Mar 1, 2024 · Class I · Z-1693-2024: Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff.
- Feb 19, 2024 · Class I · Z-1301-2024: Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
- Jan 3, 2024 · Class I · Z-0842-2024: Due to software and controller systems that results in unexpected pump start or pump stop.
- Dec 2, 2019 · Class II · Z-0746-2020: Excessive static electricity can potentially cause unrecoverable power loss and damage to the mobile power unit that can be used to power the left ventricular assist system, which could lead to no or 
- Mar 30, 2019 · Class II · Z-2349-2019: Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak
- Mar 30, 2019 · Class II · Z-2348-2019: Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is insufficiently seated, it renders the device nonfunctional because the Outflow Graft connection will leak
- Apr 5, 2018 · Class I · Z-1774-2018: Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious advers

Source page: https://510kreport.com/device/P160054
Methodology: https://510kreport.com/methodology