HeartWare Ventricular Assist System Controller Product Usage: For use… — Class I medical device recall Z-0005-2017
Terminated recall by Heartware, Inc., reported 2016-10-26, distributed nationwide. Loose connector ports in controller body.
| Recall number | Z-0005-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2016-06-08 |
| Classified | 2016-10-17 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2020-03-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, FR, GB, LB, MY, SE |
| Model numbers | 1400, 1401XX, 1403US, 1407XX |
Product
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Reason for recall
Loose connector ports in controller body.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0005-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.