HeartWare Ventricular Assist System

• • Ongoing Z-0475-2024 FDA Class II ·initiated 31 Oct 2023

  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 actions and (2) instructions relating to the useful life of the HVAD system components

• • Ongoing Z-1993-2023 FDA Class II ·initiated 16 May 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 Autologs web portal.

• • Ongoing Z-1512-2022 FDA Class I ·initiated 28 Jun 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 charged while discharging.

• • Ongoing Z-1266-2022 FDA Class I ·initiated 5 May 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 holding a complete charge or properly recharging.

• • Ongoing Z-1207-2022 FDA Class I ·initiated 14 Apr 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 into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.

• 6 recalls, same reason

  • Ongoing Z-1105-2022 FDA Class II ·initiated 30 Mar 2022
  • Ongoing Z-1106-2022 FDA Class II ·initiated 30 Mar 2022
  • Ongoing Z-1104-2022 FDA Class II ·initiated 30 Mar 2022
  • Ongoing Z-1107-2022 FDA Class II ·initiated 30 Mar 2022
  • Ongoing Z-1102-2022 FDA Class II ·initiated 30 Mar 2022
  • Ongoing Z-1103-2022 FDA Class II ·initiated 30 Mar 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 Device (HVAD) system.

• • Ongoing Z-1110-2022 FDA Class II ·initiated 30 Mar 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.

• • Ongoing Z-0726-2022 FDA Class II ·initiated 27 Jan 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 lubricant that is applied to the pins as a mitigation for power switching.

• • Ongoing Z-2478-2021 FDA Class II ·initiated 6 Aug 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 to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair.

• 10 recalls, same reason

  • Ongoing Z-2191-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2188-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2194-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2193-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2189-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2192-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2197-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2190-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2195-2021 FDA Class I ·initiated 3 Jun 2021
  • Ongoing Z-2196-2021 FDA Class I ·initiated 3 Jun 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 mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.

• 6 recalls, same reason

  • Ongoing Z-1339-2021 FDA Class I ·initiated 26 Feb 2021
  • Ongoing Z-1340-2021 FDA Class I ·initiated 26 Feb 2021
  • Ongoing Z-1341-2021 FDA Class I ·initiated 26 Feb 2021
  • Ongoing Z-1336-2021 FDA Class I ·initiated 26 Feb 2021
  • Ongoing Z-1338-2021 FDA Class I ·initiated 26 Feb 2021
  • Ongoing Z-1337-2021 FDA Class I ·initiated 26 Feb 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 inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.

• • Ongoing Z-1469-2021 FDA Class II ·initiated 26 Feb 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 there is an intermittent problem and the cause of the alarm can be evaluated by analysis of the controller log files. The Patient Manual (PM) is being updated to instruct patients to contact their clinicians if they cannot identify an alarm before it is cleared as it might mean there is an intermittent problem. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87604

• • Ongoing Z-1438-2021 FDA Class II ·initiated 26 Feb 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, which is a "beep" and not "audible click", to clarify under what alarm conditions a beep will not be heard, and identify alternate confirmation methods (visual indicator) for successful connection. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87456 and 87603

• • Ongoing Z-1426-2021 FDA Class I ·initiated 26 Feb 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 being updated to clarify use of the support strap and wear instructions in addition to cleaning instructions of the carrying cases. The IFU and PM are being updated to add a useful life for the carrying cases. The PM is being updated to inform users to keep the driveline cover on when disconnecting and reconnecting the driveline. The IFU and PM are being updated to clarify the power-up sequence that causes the alarm indicator LEDs and both sets of battery LEDs to turn red for 2.5 seconds while the LCD displays the power-on message. NOTE: this update is included in the February 2021 Urgent Medical Device Notice also covered in recalls 87603 and 87604

• • Ongoing Z-0946-2021 FDA Class I ·initiated 19 Nov 2020

  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 pump in the overall population.

• 5 recalls, same reason

  • Ongoing Z-2057-2020 FDA Class I ·initiated 3 Apr 2020
  • Ongoing Z-2055-2020 FDA Class I ·initiated 3 Apr 2020
  • Ongoing Z-2059-2020 FDA Class I ·initiated 3 Apr 2020
  • Ongoing Z-2058-2020 FDA Class I ·initiated 3 Apr 2020
  • Ongoing Z-2056-2020 FDA Class I ·initiated 3 Apr 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.

• 2 recalls, same reason

  • Ongoing Z-1427-2020 FDA Class I ·initiated 23 Jan 2020
  • Ongoing Z-1428-2020 FDA Class I ·initiated 23 Jan 2020

  Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.

• • Ongoing Z-1903-2018 FDA Class I ·initiated 2 May 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 unintended switching to the secondary power source and/or unexpected audible tones (beeping). The interruption typically lasts 1-2 seconds, due to oxidation between power source connector and socket.

• • Ongoing Z-1832-2017 FDA Class I ·initiated 10 Mar 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 clinicians informing them that a new, improved splice kit is available.

• • Ongoing Z-1538-2017 FDA Class I ·initiated 3 Feb 2017

  Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)

• • Ongoing Z-0006-2017 FDA Class I ·initiated 17 Aug 2016

  Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.

• • Ongoing Z-1731-2015 FDA Class I ·initiated 29 Apr 2015

  Complaints with the HVAD Internal Controller Alarm Battery failures.

• • Ongoing Z-1604-2015 FDA Class I ·initiated 29 Apr 2015

  Failures of the splice repair kit if exposed to excessive force.

• • Ongoing Z-1726-2015 FDA Class I ·initiated 29 Apr 2015

  Complaints with the HVAD Retraction of Pins within the driveline connector.

• • Ongoing Z-1917-2015 FDA Class II ·initiated 29 Apr 2015

  Complaints with the HVAD Abnormal Power Source Switching.

• • Ongoing Z-1698-2015 FDA Class I ·initiated 29 Apr 2015

  HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.

• • Ongoing Z-1751-2015 FDA Class II ·initiated 29 Apr 2015

  Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.

• • Terminated Z-2072-2021 FDA Class II ·initiated 28 May 2021

  The pump has an impeller with a shroud height that did not meet the lower control limit.

• • Terminated Z-0582-2019 FDA Class II ·initiated 19 Nov 2018

  HVAD Battery Charger units manufactured with wrong inductors.

• • Terminated Z-0067-2019 FDA Class II ·initiated 28 Aug 2018

  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.

• • Terminated Z-0005-2017 FDA Class I ·initiated 8 Jun 2016

  Loose connector ports in controller body.

• • Terminated Z-1887-2016 FDA Class I ·initiated 7 Jan 2016

  Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

• • Terminated Z-1131-2015 FDA Class I ·initiated 16 Jan 2015

  The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.

• • Terminated Z-1607-2014 FDA Class II ·initiated 16 Apr 2014

  Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.

• • Terminated Z-1471-2014 FDA Class I ·initiated 6 Dec 2013

  The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.

• • Terminated Z-1813-2013 FDA Class II ·initiated 16 May 13

  Potential to electrostatic discharged (ESD)

Full name

Heartware Left Ventricular Assist Device System

Trade name

Heartware Ventricular Assist System

Generic name

Ventricular (assist) bypass

PMA number

P100047 ↗

FDA product code

DSQ

Device class

Class III

Advisory committee

Cardiovascular

FDA decision

APPR Approved

• BB11A61R10

  Class II

  FDA 510(k) K171979 Active Cleared 27 Oct 2017 GUDID on market

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• What is the primary clinical purpose of the HeartWare Left Ventricular Assist Device System, and in which settings is it approved for use?

  The HeartWare Left Ventricular Assist Device System is designed to provide mechanical circulatory support as a bridge-to-transplant for patients with refractory end-stage left ventricular heart failure who are at risk of death. It is approved for use in both in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter, as outlined in its FDA-authorized indications.

• Is the HeartWare Ventricular Assist System intended for single-use, or does it require reprocessing and sterilization?

  The HeartWare Ventricular Assist System is not a single-use device. It is supplied as a reusable system and requires proper sterilization and maintenance as specified in the accompanying instructions to ensure safe and effective use over multiple procedures.

• What regulatory pathway was followed for FDA approval of this device, and what is the associated PMA number?

  The HeartWare Ventricular Assist System received FDA approval through the Premarket Approval (PMA) pathway, which is required for Class III devices like ventricular assist systems. The associated PMA number is P100047, reflecting its regulatory clearance for bridge-to-transplant use.

• Does the device come with multiple models or sizes, and if so, how are they identified?

  Yes, the HeartWare Ventricular Assist System includes multiple models, each identified by a unique FEI (Facility Equipment Identifier) number. These identifiers (e.g., 3005228872, 3001236763) correspond to different configurations or batches of the device, allowing for traceability and compatibility with specific clinical or procedural needs.