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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.

Medtronic PLC only finalized its purchase of ventricular assist device innovator HeartWare International Inc. on Aug. 23, but the company has already added two more high-risk class I voluntary recalls to an ongoing series of reported issues with HeartWare's devices.

The device giant announced the class I designation of the recalls, which affect HeartWare’s HVAD System and HVAD Pump Implant Kits, on Sept. 30.

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