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Medtronic HVAD Recall Given High-Risk Class I Designation

 
• By Elizabeth Orr

A welding defect may allow moisture to enter affected heart pumps, which can lead to device failure, the US FDA explained. Medtronic first announced the recall in April. 

Digital model of the heart.
• Source: Shutterstock

A recall of Medtronic’s Heartware Ventricular Assist Device (HVAD) pump implant kit has been slapped with high-risk class I status by the US Food and Drug Administration, the agency announced on 8 June.

The system, which helps the heart continue to pump blood, is used both as a bridge to cardiac transplant for patients in end-stage heart failure and as a treatment in...

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