HeartWare VAD Battery Alert Tagged As Class I Recall
This article was originally published in The Gray Sheet
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.
You may also be interested in...
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.
The deal gives Medtronic its first ventricular-assist devices and gives struggling HeartWare a needed boost.
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.