PMA · Approved
Recalled · Class I · 2026HeartMate 3™ Left Ventricular Assist System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · DSQ Ventricular (Assist) Bypass
Approved on Aug 23, 2017 through premarket approval, which rests on the device’s own clinical evidence after a 261-day review. It has a Class I recall. It has been recalled 18 times, including 9 Class I recalls.
- Decided
- Aug 23, 2017
- Review
- 261 days
- Class
- Class III
- Product code
- DSQ
- Recalls
- 18 (9 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P160054 has 132 supplements since 2017: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2017 | 2 |
| 2018 | 12 |
| 2019 | 9 |
| 2020 | 9 |
| 2021 | 8 |
| 2022 | 7 |
| 2023 | 18 |
| 2024 | 26 |
| 2025 | 21 |
| 2026 | 20 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 13, 2026 | Class II | Z-2520-2026 | Under Investigation by firm | Due to 11 volt Backup Battery failures. |
| May 13, 2026 | Class II | Z-2519-2026 | Under Investigation by firm | Due to 11 volt Backup Battery failures. |
| May 13, 2026 | Class II | Z-2518-2026 | Under Investigation by firm | Due to 11 volt Backup Battery failures. |
| Oct 9, 2025 | Class II | Z-0505-2026 | Device Design | 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 | Device Design | 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 | Vendor change control | 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 | Vendor change control | 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 | Process control | 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 indicate Yellow Wrench or No External… |
| Jun 25, 2024 | Class II | Z-2583-2024 | Process design | 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 circuit board assemblies, which could… |
| May 8, 2024 | Class I | Z-1921-2024 | Device Design | 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 initiate a command, which may lead to… |
| Mar 1, 2024 | Class I | Z-1692-2024 | Device Design | 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 | Device Design | 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 | Material/Component Contamination | 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 | Software design | Due to software and controller systems that results in unexpected pump start or pump stop. |
| Dec 2, 2019 | Class II | Z-0746-2020 | Device Design | 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 reduced blood flow from the left… |
| Mar 30, 2019 | Class II | Z-2349-2019 | Process design | 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 during the implant procedure. |
| Mar 30, 2019 | Class II | Z-2348-2019 | Process design | 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 during the implant procedure. |
| Apr 5, 2018 | Class I | Z-1774-2018 | Device Design | 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 adverse events such as hemodynamic… |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DSQ devicesDSQ Ventricular (Assist) Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DSQ
50in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSQ
Too few DSQ 510(k)s in any year since 2007 to give a median.
Recalls per year · DSQ
4in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DSQ
10,419in 2025
MAUDE reports naming product code DSQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | — | 4 | 224 |
| 2008 | 5 | — | 1 | 264 |
| 2009 | 9 | — | 4 | 529 |
| 2010 | 12 | — | 1 | 687 |
| 2011 | 4 | — | 0 | 1,082 |
| 2012 | 20 | — | 1 | 2,120 |
| 2013 | 36 | — | 0 | 2,941 |
| 2014 | 30 | — | 0 | 3,903 |
| 2015 | 24 | — | 0 | 6,771 |
| 2016 | 37 | — | 2 (2) | 7,190 |
| 2017 | 36 | — | 0 | 9,055 |
| 2018 | 35 | — | 3 | 12,660 |
| 2019 | 34 | — | 1 | 20,216 |
| 2020 | 48 | — | 1 (1) | 14,239 |
| 2021 | 38 | — | 1 | 15,766 |
| 2022 | 33 | — | 11 | 15,994 |
| 2023 | 48 | — | 9 | 13,055 |
| 2024 | 61 | — | 1 (1) | 13,046 |
| 2025 | 50 | — | 4 | 10,419 |
| 2026 | 46 | — | 4 | — |
https://510kreport.com/device/P160054 · printed Nov 6, 2026
Cite this page
510(k) Report. “P160054: HeartMate 3™ Left Ventricular Assist System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P160054
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026