PMA · Approved
Recalled · Class I · 2023Heartware Ventricular Assist System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic · DSQ Ventricular (Assist) Bypass
Approved on Nov 20, 2012 through premarket approval, which rests on the device’s own clinical evidence after a 693-day review. It has a Class I recall. It has been recalled 60 times, including 40 Class I recalls.
- Decided
- Nov 20, 2012
- Review
- 693 days
- Class
- Class III
- Product code
- DSQ
- Recalls
- 60 (40 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P100047 has 227 supplements since 2012: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
2012high 24 (2017) · low 6 (2012)2026
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2012 | 6 |
| 2013 | 23 |
| 2014 | 21 |
| 2015 | 14 |
| 2016 | 19 |
| 2017 | 24 |
| 2018 | 18 |
| 2019 | 15 |
| 2020 | 24 |
| 2021 | 18 |
| 2022 | 12 |
| 2023 | 10 |
| 2024 | 7 |
| 2025 | 8 |
| 2026 | 8 |
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 31, 2023 | Class II | Z-0475-2024 | Labeling design | Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting… |
| May 16, 2023 | Class II | Z-1993-2023 | Software change control | Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal. |
| Jun 28, 2022 | Class I | Z-1512-2022 | Device Design | Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging. |
| May 5, 2022 | Class I | Z-1266-2022 | Process control | Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly… |
| Apr 14, 2022 | Class I | Z-1207-2022 | Under Investigation by firm | The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the… |
| Mar 30, 2022 | Class II | Z-1106-2022 | Labeling design | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. |
| Mar 30, 2022 | Class II | Z-1103-2022 | Labeling design | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. |
| Mar 30, 2022 | Class II | Z-1105-2022 | Labeling design | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. |
| Mar 30, 2022 | Class II | Z-1104-2022 | Labeling design | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. |
| Mar 30, 2022 | Class II | Z-1110-2022 | Labeling design | Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system. |
| Mar 30, 2022 | Class II | Z-1107-2022 | Labeling design | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. |
| Mar 30, 2022 | Class II | Z-1102-2022 | Labeling design | Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system. |
| Jan 27, 2022 | Class II | Z-0726-2022 | Labeling design | Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins… |
| Aug 6, 2021 | Class II | Z-2478-2021 | Device Design | There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the… |
| Jun 3, 2021 | Class I | Z-2197-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2189-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2188-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2192-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2191-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2196-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2194-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2195-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2190-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| Jun 3, 2021 | Class I | Z-2193-2021 | Unknown/Undetermined by firm | Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when… |
| May 28, 2021 | Class II | Z-2072-2021 | Nonconforming Material/Component | The pump has an impeller with a shroud height that did not meet the lower control limit. |
| Feb 26, 2021 | Class I | Z-1341-2021 | Device Design | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the… |
| Feb 26, 2021 | Class I | Z-1336-2021 | Device Design | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the… |
| Feb 26, 2021 | Class I | Z-1339-2021 | Device Design | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the… |
| Feb 26, 2021 | Class II | Z-1438-2021 | Device Design | IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the controller, which is a "beep" and not "audible… |
| Feb 26, 2021 | Class I | Z-1340-2021 | Device Design | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the… |
| Feb 26, 2021 | Class I | Z-1338-2021 | Device Design | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the… |
| Feb 26, 2021 | Class II | Z-1469-2021 | Device Design | IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period may mean there is an intermittent problem and the… |
| Feb 26, 2021 | Class I | Z-1426-2021 | Device Design | Medtronic HeartWare HVAD System Instructions for Use (IFU) and Patient Manual (PM) updates regarding: Carrying Cases, Driveline Cover Orientation, and Controller Power Up Sequence issues. The PM is being updated to clarify use of the… |
| Feb 26, 2021 | Class I | Z-1337-2021 | Device Design | There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the… |
| Nov 19, 2020 | Class I | Z-0946-2021 | Under Investigation by firm | Pumps manufactured with impellers from a subset of lots from a single supplier are failing to initially start, restart, or experiencing a delay in restart within the maximum number of restart attempts at a rate substantially higher than… |
| Apr 3, 2020 | Class I | Z-2057-2020 | Device Design | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. |
| Apr 3, 2020 | Class I | Z-2059-2020 | Device Design | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. |
| Apr 3, 2020 | Class I | Z-2058-2020 | Device Design | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. |
| Apr 3, 2020 | Class I | Z-2056-2020 | Device Design | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. |
| Apr 3, 2020 | Class I | Z-2055-2020 | Device Design | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. |
| Jan 23, 2020 | Class I | Z-1428-2020 | Device Design | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. |
| Jan 23, 2020 | Class I | Z-1427-2020 | Device Design | Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port. |
| Nov 19, 2018 | Class II | Z-0582-2019 | Other | HVAD Battery Charger units manufactured with wrong inductors. |
| Aug 28, 2018 | Class II | Z-0067-2019 | Device Design | Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing. |
| May 2, 2018 | Class I | Z-1903-2018 | Device Design | Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary… |
| Mar 10, 2017 | Class I | Z-1832-2017 | Device Design | In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new… |
| Feb 3, 2017 | Class I | Z-1538-2017 | Software design | Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0) |
| Aug 17, 2016 | Class I | Z-0006-2017 | Component design/selection | Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults. |
| Jun 8, 2016 | Class I | Z-0005-2017 | Device Design | Loose connector ports in controller body. |
| Jan 7, 2016 | Class I | Z-1887-2016 | Software design | Heartware Ventricular Assist System Battery Cell experiencing premature depletion. |
The 5 latest of 50 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. 2012, this device’s year, is highlighted.
FDA decisions per year · DSQ
50in 2025
2007high 61 (2024) · low 4 (2011)2026
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
2007high 11 (2022) · low 0 (2011)2026
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · DSQ
10,419in 2025
2007high 20,216 (2019) · low 224 (2007)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/P100047 · printed Nov 6, 2026
Cite this page
510(k) Report. “P100047: Heartware 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/P100047
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026