| HeartWare HVAD™ System™ product advisory | Communication date | Description | Link |
|---|---|---|---|
| HVAD Instructions for Use and Patient Manual Update | October 2023 | Medtronic is writing to inform about upcoming updates to the HVAD™ system instructions for use (IFU) and patient manual (PM). 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. | October 2023 - https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiac-rhythm/left-ventricular-assist-device-lvad/hvad-system-useful-life-ifu-pm-update.pdf |
| HeartWare HVAD™ System™ product advisory: Medtronic HeartWare™ HVAD™ Monitor AutoLogs | May 2023 September 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. When attempting to submit logfiles to the Autologs web portal (autologs.medtronic.com) from these recently updated monitors, an error will be displayed stating that the files cannot be processed. This issue affects all logfiles downloaded from these recently updated Model 1521 monitors. There is no impact on the monitor’s functionality or ability to download the logfiles to the USB flash drive, display system performance, or adjust controller parameters. A workaround has been identified to provide instructions for Technical Services Engineers to remove the added text string if a user reports an error submitting the logfiles through AutoLogs. | May 2023 - https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiac-rhythm/left-ventricular-assist-device-lvad/heartware-hvad-monitor-autologs-product-advisory-letter.pdf September 2023 - https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiac-rhythm/left-ventricular-assist-device-lvad/medtronic-heartware-hvad-monitor-autologs-letter-2023.pdf |
| Hardened Driveline Cover | November 2022 | Medtronic is writing to alert you to important safety information related to the controller driveline cover of the HVAD™ System. Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. | https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-hardened-driveline-cover-notice.pdf |
| System Battery Performance Update | June 2022 May 2023 |
Medtronic is taking actions to address two separate battery issues: 1) a weld nonconformance has been identified within some batteries that can cause the battery to fail to deliver power (communicated in May 2022 to accounts with affected batteries and here for the unaffected accounts), 2) an interaction between the battery software configuration and the battery circuit board can cause electrical faults within some batteries. | June - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-system-battery-performance-update.pdf May - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/system-battery-performance-update.pdf |
| Battery Weld | May 2022 January 2023 |
Medtronic is issuing a recall of a single lot of HeartWare™ Ventricular Assist Device (HVAD™) System batteries. This single lot of batteries has been found to have multiple occurrences of a welding defect affecting internal components within the HVAD Battery. If present, the welding defect may cause the battery to malfunction and no longer provide power and/or prevent the battery from holding a complete charge or properly recharging January 2023 update: A recall was issued for an additional 12 HVAD batteries outside of the previous lot. Utilizing a review of an electrical signature that may be indicative of the battery weld defect, the batteries are requested to be returned for further engineering analysis. |
May - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/heartware-medical-device-notice-battery-weld-may-2022.pdf January - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/heartware-medical-device-notice-battery-weld-january-2023.pdf |
| Center Post Weld Investigation | April 2022 July 2022 |
Medtronic is writing to inform you of a potential issue with the HeartWare™ Ventricular Assist Device (HVAD™) System associated with a pump weld non-conformance where (3) pumps were identified to have an impeller rotating non-concentrically and contacting the center post of the pump. Medtronic's investigation was not able to conclusively isolate the issue to a specific subset of pumps. | April - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/heartware-medical-device-notice-update-may-2022.pdf July - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-update-july-2022.pdf |
| System Power Source Connector Cleaning | February 2022 | Medtronic is writing to provide updated cleaning instructions for the HVAD™ Controller AC Adapter, DC Adapter, and Battery. While performing a review of the IFU and PM it was identified that additional clarity was required around cleaning the Power Source Connectors (Controller AC Adapter, DC Adapter, and Battery). The pins of the power source connectors are coated with a lubricant, that should not be removed as it is intended to help prevent unexpected power switching. Power switching can occur when there are transient interruptions to the electrical connection with the HVAD System power sources. |
https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-use-instructions-update-notice-feb-2022.pdf |
| Strain Relief Repair | August 2021 | Medtronic is writing to alert you to important safety information related to HVAD™ Systems that have undergone a driveline strain relief repair performed by a Medtronic field service representative. Medtronic is communicating to inform you and your patients of the potential for this issue. Medtronic internal testing has shown that it may be difficultto pull back the driveline cover over a strain relief repair when attempting to access the driveline connector. Difficulty in pulling back the driveline cover over a strain relief repair may cause a delay in accessing the driveline connector. This delay may lead to a prolonged pump stop if access to the driveline connector is required to address a marginal driveline connection or change controllers. In addition, pulling back the driveline cover over a driveline strain relief repair may compromise the integrity of the repair. |
https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/clinician-letter-following-physician-no-patient-with-strain-relief-repair.pdf https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/clinician-letter-following-physician-with-patient-with-strain-relief-repair.pdf https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/clinician-letter-vad-coordinator-hcp-no-patient-with-strain-relief-repair.pdf https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/clinician-letter-vad-coordinator-hcp-patient-with-strain-relief-repair.pdf |
| HVAD System Recall | June 2021 July 2021 |
Medtronic is issuing a global communication announcing our decision to stop the distribution and sale of the HeartWare Ventricular Assist Device (HVAD)™ System. Physicians should immediately stop new implantsof the Medtronic HVAD™ System. Prophylactic explant of the HVAD™ System is not recommended at this time. | June - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-june-2021.pdf July - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-july-2021.pdf |
| IFU Update | February 2021 | Medtronic is writing to infor you of updates to the HVAD™ System Instructions for Use (IFU) and Patient Manual (PM). These updates (1) provide new information relating to the useful life of the HVAD™ System carrying cases (Waist Pack, Shoulder Pack, and Convertible Patient Pack), (2) clarify the HVAD™ Controller connections, powerup sequence, and notifications, and (3) clarify expected duration of HVAD™ System alarms. The following updates are being made to the PM only: (1) provide additional information relating to the care and use instructions for the HVAD™System carrying cases and (2) provide additional information relating to the HVADTM Controller driveline cover. | https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad/hvad-urgent-medical-device-notice-feb-2021.pdf |
| Controller Ports Damage or Bent Pins | February 2021 August 2022 |
Medtronic is writing to alert you to the potential for damage or bending on the Controller port metal pins due to wear on the HVAD™ Power Cables (AC adapter, DC adapter, and batteries), and HeartWare™ Monitor data cables. | February 2021 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad/hvad-urgent-medical-device-notice-bent-pins-feb-2021.pdf August 2022 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-system-controller-port-product-notification-update-2022.pdf |
| HVAD Delay or Failure to Restart | December 2020 May 2021 December 2021 June 2022 October 2022 August 2023 April 2024 |
Medtronic has identified a subset (defined as subgroups 1 and 2) of HVAD™ pumps may experience a delay to restart or failure to restart
August 2023 Update: Medtronic is providing an update to communicate current failure rates associated with a failure/delay to restart pump event and provide information about an additional subgroup population, subgroup 3. Initially, the restart failure rate of pumps in subgroup 3 was in line with that of the general HVAD population. However, as the duration of support has increased, the failure rate has risen and now resembles the higher rate observed in subgroup 1. Patient management recommendations previously communicated for subgroups 1 and 2 have not changed and also apply to subgroup 3. |
December 2020 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/heartware-hvad-medical-device-correction-december-2020.pdf May 2021 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/heartware-hvad-medical-device-correction-updated-may-2021.pdf December 2021 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-prod-perf-update/hvad-urgent-medical-device-notice-december-2021.pdf June 2022 -https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-update-june-2022.pdf October 2022 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-urgent-medical-device-notice-update-oct-22.pdf August 2023 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/hvad-delay-failure-restart-letter.pdf April 2024 - https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiac-rhythm/left-ventricular-assist-device-lvad/hvad-system-update-power-source-autologs.pdf |
| HVAD Outflow Graft and Strain Relief | April 2020 September 2020 |
Medtronic has identified that 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. We are providing additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure. No action is needed for patients currently implanted with an HVAD™ Pump since the potential for damage applies to the pre-implant Outflow Graft and Strain Relief assembly procedure. | April 2020 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/physician-letter-hvad-outflow-graft-fca.pdf September 2020 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/physician-letter-hvad-outflow-graft-fca-updated2020.pdf |
| Battery Charger | November 2018 | Medtronic has identified specific Serial Numbres of HVAD™ battery charger units that may have been manufactured with an incorrect circuit component. This subset may exhibit one or more of the battery charging bays not fully charging the battery and/or battery charger indicators (LED) not lighting. | https://www.medtronic.com/us-en/healthcare-professionals/products/product-performance/heartware-hvad-system-battery-charger.html |
| Controller Housing Integrity | August 2018 | Medtronic has identified HVAD™ System Controller units with Serial Numbers in the range of CON300175 – CON320540 may not meet the labeled standard for protection against water or fluid ingress. Specifically, some units have the potential to develop hairline cracks at the power ports of the controller housing. | https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiac-rhythm/left-ventricular-assist-device-lvad/clinician-notification-letter-hvad-controller-housing-integrity-fca-v2.pdf |
| Unexpected Power Source Switching | May 2018 May 2018 October 2019 |
Medtronic has identified the potential for a transient interruption of the electrical connection between an HVAD™ System power source (Battery, AC Adapter, or DC Adapter) and the HVAD Controller that may result in unintended power switching to the secondary power source and/or unexpected audible tones (“beeping”). | May 2018 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/Clinician-Letter-HVAD-Power-Switching-FCA.pdf May 2018 updated - https://www.medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiac-rhythm/left-ventricular-assist-device-lvad/HVAD-Power-Switching-FCA-update-to-Clinican-Letter-v3.pdf October 2019 - https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/customer-letter-hvad-power-switching-fca-version-a.pdf |