Medtronic HVAD Class I Recalls Keep On Coming
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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HeartMate and Medtronic’s HeartWare ventricular assist device platforms have been tagged with class I recalls in the last few weeks based on separate safety issues.
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.