# FDA 483 - Heartware, Inc. - January 24, 2014

Source: https://www.keypedia.com/records/483/heartware-inc/c477e339-7f14-4aaf-bd4c-1515bd0c6e95

> FDA 483 for Heartware, Inc. on January 24, 2014. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Heartware, Inc.
- Inspection Date: 2014-01-24
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: HeartWare Inc. in Miami Lakes, FL, was inspected and received a Form FDA-483 with seven observations. The inspection revealed significant deficiencies in corrective and preventive actions, purchasing controls, design validation, complaint investigations, process validation, software validation, and design transfer procedures. These issues are particularly concerning given multiple reports of patient deaths and serious injuries associated with their HVAD devices, battery failures, and driveline connector problems.

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## Related Officers

- [Principal ](https://www.keypedia.com/people/richard-k-vogel/3ddd8bff-24fd-40ee-b0a7-fb5333a520f5)

Company: https://www.keypedia.com/companies/heartware-inc/fc9e730f-ca60-46ac-9b88-23a426f2dbfe

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6