PMA · Approved
Recalled · Class I · 2025Thoratec Heartmate II 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 Apr 21, 2008 through premarket approval, which rests on the device’s own clinical evidence after a 486-day review. It has a Class I recall. It has been recalled 18 times, including 12 Class I recalls.
- Decided
- Apr 21, 2008
- Review
- 486 days
- Class
- Class III
- Product code
- DSQ
- Recalls
- 18 (12 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P060040 has 125 supplements since 2008: 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 |
|---|---|
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 9 |
| 2011 | 1 |
| 2012 | 8 |
| 2013 | 6 |
| 2014 | 8 |
| 2015 | 9 |
| 2016 | 16 |
| 2017 | 7 |
| 2018 | 2 |
| 2019 | 3 |
| 2020 | 4 |
| 2021 | 3 |
| 2022 | 6 |
| 2023 | 10 |
| 2024 | 13 |
| 2025 | 10 |
| 2026 | 6 |
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 |
|---|---|---|---|---|
| Oct 9, 2025 | Class II | Z-0507-2026 | 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-0508-2026 | 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… |
| 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… |
| Feb 19, 2024 | Class I | Z-1300-2024 | Material/Component Contamination | 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 | Device Design | 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 to recall Z-1227/1230-2014. |
| Mar 30, 2017 | Class I | Z-2052-2017 | Device Design | 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 to recall Z-1227/1230-2014. |
| Mar 30, 2017 | Class I | Z-2051-2017 | Device Design | 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 to recall Z-1227/1230-2014. |
| Mar 4, 2014 | Class I | Z-1230-2014 | Device Design | 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 model. |
| Mar 4, 2014 | Class I | Z-1228-2014 | Device Design | 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 model. |
| Mar 4, 2014 | Class I | Z-1227-2014 | Device Design | 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 model. |
| Mar 4, 2014 | Class I | Z-229-2014 | Device Design | 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 model. |
| Feb 23, 2012 | Not classified | Z-1228-2012 | Device Design | 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 | Device Design | Connection failure-- product may malfunction because of bent pins or broken wires in power cord connection |
| Oct 14, 2009 | Not classified | Z-0422-2010 | Other | 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 cases dislodged from the battery clip… |
| Oct 24, 2008 | Not classified | Z-0496-2009 | Device Design | 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 may result in damage that has the… |
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. 2008, 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/P060040 · printed Nov 6, 2026
Cite this page
510(k) Report. “P060040: Thoratec Heartmate II 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/P060040
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026