FDA classifies VAD recall as Class 1

Medtronic announced that its voluntary field action regarding a ventricular assist device system has been ranked as a Class 1 recall by the FDA.

Since the original safety notices in April 2015 and April 2016, which notified clinicians of possible injury and death from functionality issues, the company issued an updated system and alerted clinicians worldwide, according to a press release.

The updated ventricular assist device system addressed the safety issues encountered in the original system (HVAD System Controllers and DC Adapters).

According to the release, improvements included:

Reinforced power and serial port alignment guides reduce the rate of damage to the connector pins.

The system now signals when the battery is almost depleted.

Housing and connectors were redesigned to stop them from loosening and prevent damage from fluids.

The FDA approved the updated system in April 2017.

Medtronic started removing the recalled system and adapters from various areas including the U.S., according to the release. The company stated it has also provided clinicians with recommendations for a smooth transition, which includes required training on the new system, replacing patients’ controllers and adapters, notifying patients who require prompt controller exchanges and training hospital staff on how to educate patients on the functionality of the updated system.

According to the release, patients with questions about their system should talk with their physician or VAD coordinator.