The FDA determined that Medtronic’s voluntary recall of its HVAD system controllers and DC adapters was a class I recall, according to a Medtronic news release on April 18.
Medtronic had previously announced field safety notices related to the products in April 2015 and April 2016. The company said that issues with the HVAD system controller could lead to potential injury and death due to worn alignment guides, internal battery failure and loose power and data connectors.
The FDA defines a class I recall as “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The FDA approved updated HVAD system controllers and DC adapters earlier this month. Medtronic said it has started to remove HVAD Controllers (product codes 1400,1401US and 1407US) and related adapters (product code 1435) in the U.S. and other countries.
Medtronic acquired the HVAD system in its $1.1 billion deal for HeartWare International in August 2016. HeartWare has had numerous issues with the HVAD system, a small, less invasive ventricular assist device.
HeartWare voluntarily recalled more than 18,000 of its ventricular assist device in June 2016 after discovering the batteries may lose power prematurely. In June 2015, the company recalled 1,763 HeartWare devices, which was considered a class I recall.