Another Class I Recall For HeartWare's HVAD System
Medtronic announced FDA's high-risk designation of recalls from its new subsidiary’s products on Sept. 30. HeartWare products have been subject to a total of nine class I recalls since 2013.
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With recent actions, the Medtronic HeartWare left-ventricular assist device system, acquired last year, has 11 class I recall actions to its name in the US.
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An FDA recall notice states that HeartWare, which is being acquired by Medtronic, has recalled almost 19,000 ventricular-assist device batteries due to a risk of losing charge prematurely.