HeartWare HVAD System Controller The HeartWare Ventricular Assist… — Class I medical device recall Z-1538-2017
Ongoing recall by Heartware, reported 2017-05-03, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HV
| Recall number | Z-1538-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Miami Lakes, FL, United States |
| Recall initiated | 2017-02-03 |
| Classified | 2017-04-26 |
| Reported by FDA | 2017-05-03 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, IL, IN, IT, JP, KR, KW, LB, LT, LU, MY, NL, NO, NZ, PL, SA, SG, TR, VN, ZA |
Product
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated 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 Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Reason for recall
Product recall of all HVAD Controllers currently on the market and to exchange them for the next generation HVAD Controller (Controller2.0)
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-1538-2017. 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.