FDAnews Device Daily Bulletin

Medtronic Recalls Newly Acquired HeartWare Devices

Oct. 19, 2016

The FDA has classified Medtronic’s global recalls of its HeartWare International HVAD system as Class I.

HeartWare had issued two global recalls due serious risks associated with its heart ventricular assist devices (HVAD), which include a ventricular assist device that pumps blood to the body and a controller that monitors the pump.

The company warned of potential damage to controllers from exposure to moisture through loose power and data connectors. HeartWare also issued a global recall for certain models of unimplanted HVAD pump kits sold to hospitals, which are also susceptible to electrical faults and connection failures.

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