The US Food and Drug Administration (FDA) has classified Medtronic’s recently initiated voluntary field action related to its HVAD system controllers and direct current adapters as a class I recall.
Medtronic began notifying clinicians outside of the USA in March 2017 about updated HVAD system controllers and direct current adapters that were developed following two previously communicated Field Safety Notices that occurred in April 2015 and April 2016. The FDA approved the updated controller on April 7, 2017, and Medtronic began notifying US clinicians about the updated HVAD Controllers and DC Adapters on April 14, 2017.
In April 2015 and April 2016, Medtronic notified clinicians about potential safety issues with the current HVAD System Controller that could lead to possible injury and death due to worn alignment guides, internal “double disconnect (no power) alarm” battery failure, and loose power and data connectors.
With the introduction of the updated controller, Medtronic has begun to remove current HVAD controllers in select geographies, including the USA. Medtronic also has begun to remove the related adapters, Instructions for Use, Patient Manuals and Emergency Responder Guides.