HeartWare Ventricular Assist System — Class I medical device recall Z-1131-2015
Terminated recall by HeartWare Inc, reported 2015-03-04, distributed nationwide. The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controlle
| Recall number | Z-1131-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartWare Inc, Miami Lakes, FL, United States |
| Recall initiated | 2015-01-16 |
| Classified | 2015-02-25 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2020-02-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, BR, CA, CH, DE, FI, FR, GB, GR, IL, IN, IT, JP, LT, MY, NL, NO, NZ, PL, SE, SG, TR, ZA |
| Quantity | 4,845 |
| Serial numbers | CON000001 |
| Model numbers | 1400, 1401US, 1401XX |
Product
HeartWare Ventricular Assist System (HeartWare 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 HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for recall
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
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-1131-2015. 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.