The FDA issued a warning June 3 alerting healthcare providers to stop implants that use Medtronic's Heartware Ventricular Assist Device System.
The FDA issued the warning in response to observations that the system showed a higher frequency of neurological adverse effects and mortality compared to other devices and complaints that the device's internal pump delays or fails to restart.
Medtronic issued a letter June 3 stating that it was stopping the distribution and sale of the HVAD system and requested physicians refrain from new implants. The company also stated that prophylactic explant of the system was not currently recommended and that explants should be decided by physicians on a case-by-case basis. Medtronic stated it would work to actively support current patients with the HVAD implants.
The FDA advised healthcare providers to follow instructions stated in Medtronic's letter and use alternative implants going forward. It also echoed Medtronic's recommendations to continue normal use of device components and to contact Medtronic for replacement items.
The HVAD system was first approved for commercial use in 2012.