# P100047: Heartware Ventricular Assist System

- Pathway: PMA
- Applicant: Medtronic
- Decided: Nov 20, 2012 after 693 days
- Product code: DSQ (Ventricular (Assist) Bypass)
- Device class: 3
- Recalls of this device: 60 (40 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 31, 2023 · Class II · Z-0475-2024: 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
- May 16, 2023 · Class II · Z-1993-2023: 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 Autolo
- Jun 28, 2022 · Class I · Z-1512-2022: 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 charg
- May 5, 2022 · Class I · Z-1266-2022: 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 
- Apr 14, 2022 · Class I · Z-1207-2022: 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 int
- Mar 30, 2022 · Class II · Z-1106-2022: 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 Devic
- Mar 30, 2022 · Class II · Z-1103-2022: 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 Devic
- Mar 30, 2022 · Class II · Z-1105-2022: 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 Devic
- Mar 30, 2022 · Class II · Z-1104-2022: 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 Devic
- Mar 30, 2022 · Class II · Z-1110-2022: 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: 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 Devic
- Mar 30, 2022 · Class II · Z-1102-2022: 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 Devic
- Jan 27, 2022 · Class II · Z-0726-2022: 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 l
- Aug 6, 2021 · Class II · Z-2478-2021: 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
- Jun 3, 2021 · Class I · Z-2197-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2189-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2188-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2192-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2191-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2196-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2194-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2195-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2190-2021: 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 mortalit
- Jun 3, 2021 · Class I · Z-2193-2021: 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 mortalit
- May 28, 2021 · Class II · Z-2072-2021: 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: 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 
- Feb 26, 2021 · Class I · Z-1336-2021: 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 
- Feb 26, 2021 · Class I · Z-1339-2021: 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 
- Feb 26, 2021 · Class II · Z-1438-2021: 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,
- Feb 26, 2021 · Class I · Z-1340-2021: 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 
- Feb 26, 2021 · Class I · Z-1338-2021: 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 
- Feb 26, 2021 · Class II · Z-1469-2021: 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 the
- Feb 26, 2021 · Class I · Z-1426-2021: 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 be
- Feb 26, 2021 · Class I · Z-1337-2021: 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 
- Nov 19, 2020 · Class I · Z-0946-2021: 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
- Apr 3, 2020 · Class I · Z-2057-2020: 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: 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: 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: 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: 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: 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: 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: HVAD Battery Charger units manufactured with wrong inductors.
- Aug 28, 2018 · Class II · Z-0067-2019: 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 p
- May 2, 2018 · Class I · Z-1903-2018: 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 u
- Mar 10, 2017 · Class I · Z-1832-2017: 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
- Feb 3, 2017 · Class I · Z-1538-2017: 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: 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: Loose connector ports in controller body.
- Jan 7, 2016 · Class I · Z-1887-2016: Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

Source page: https://510kreport.com/device/P100047
Methodology: https://510kreport.com/methodology