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Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA

Retrieved on: 2021-05-21 15:56:15

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Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA. View article details on HISWAI: https://www.medtechdive.com/news/medtronic-heartware-system-hit-with-slew-of-class-i-recalls-device-reports/600586/

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... on causality and disparate nature of available data — underscores the patchwork system used by the FDA to monitor the safety of medical devices.

Article found on: www.medtechdive.com

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