Medtronic discontinues the HeartWare HVAD pumpAD
This happened after a recall in which a number of patients died.
This move was taken after a series of recalls, including 3 in 2021 alone, resulted in reports of 91 injuries and 15 deaths related to problems. FDA advised healthcare providers on June 3, 2021 to stop new implants of the HeartWare system. The FDA report states that Medtronic has “received more than 100 complaints regarding difficulty or no restart of the HVAD pump. There have been reports of 14 deaths and 13 patients required explantation.” The agency advises health care providers to use Abbott's HeartMate 3 as an alternative. See the article here
Medtronic tries to inform patients as best as possible
In an open letter to patients, Medtronic tries to provide as clear information as possible. Important things mentioned herein are:
- Medtronic recommends that you regularly contact your LVAD coordinator and follow the advice and directions of your healthcare providers. In consultation with an independent panel of clinical advisors, Medtronic does not recommend the removal or replacement of your HVAD device.
- Medtronic will continue to provide product support for the HVAD system and ensure continuous availability of peripherals, including the Pioneer controller.
- Medtronic emphasizes that you NEVER DISCONNECT the HVAD pump FROM TWO POWER SOURCES AT THE SAME TIME and always have a backup controller and fully charged spare batteries on hand.