# FDA 483 - Heartware, Inc. - September 30, 2021

Source: https://www.keypedia.com/records/483/heartware-inc/8eccb497-c1b0-47d2-b89f-a87a3abad0a2

> FDA 483 for Heartware, Inc. on September 30, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Heartware, Inc.
- Inspection Date: 2021-09-30
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Heartware, Inc. in Miami Lakes, FL, was cited for significant deficiencies across its quality system, particularly in design control, corrective and preventive actions, complaint handling, and medical device reporting. These issues, many of which are repeat observations, led to numerous confirmed complaints, including patient deaths and serious injuries, related to the HVAD™ System's performance and reliability. The inspection highlights systemic failures in ensuring product safety, efficacy, and compliance with regulatory requirements.

## Related Documents

- [483 - 2014-01-24](https://www.keypedia.com/records/483/heartware-inc/c477e339-7f14-4aaf-bd4c-1515bd0c6e95)
- [483 - 2016-05-04](https://www.keypedia.com/records/483/heartware-inc/08c011b3-65b5-47b5-bf2b-8f8b8e8f1f4b)

## Related Officers

- [Stanley R Rugene](https://www.keypedia.com/people/stanley-r-rugene/4c8374d1-b3b3-42ca-b897-8ccbcf22f5ab)
- [Dianiris C. Ayala](https://www.keypedia.com/people/dianiris-c-ayala/ba6c5538-201b-4c9a-8f23-e160db6868e6)
- [investigator](https://www.keypedia.com/people/karen-m-rodriguez/fcef1f49-583d-45ab-80e2-4c34793fd722)

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