FDA Warns Against Using Medtronic’s Ventricular Assist Device

The FDA has issued an alert cautioning health providers not to implant patients with Medtronic’s Heartware Ventricular Assist Device system, citing a high rate of neurological adverse events and death associated with the device.

The agency said it has seen a growing number of reports that indicate a higher frequency of neurological adverse events and mortality linked to the system compared to other cleared devices. The FDA also noted complaints related to the implant’s internal pump delaying or failing to restart.

Medtronic has stopped distribution and marketing of the system and has issued a letter requesting that physicians stop implants of the device. The company has received more than 100 complaints involving failures or delays in restarting the system’s pump, including 14 reported patient deaths.