HeartWare Ventricular Assist System — Class II medical device recall Z-1917-2015
Ongoing recall by HeartWare Inc, reported 2015-07-08, distributed in AL, AZ, CA, CO, CT, DC, DE, FL…. Complaints with the HVAD Abnormal Power Source Switching.
| Recall number | Z-1917-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartWare Inc, Miami Lakes, FL, United States |
| Recall initiated | 2015-04-29 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Distributed | AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CL, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, HU, IL, IN, IT, JP, KR, LB, LT, MY, NL, NO, NZ, PL, RO, SE, SG, SK, TR, ZA |
| Quantity | 3,747 currently |
| Model numbers | 1100, 1101, 1102, 1103, 1104, 1104JP, 1205 |
Product
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Reason for recall
Complaints with the HVAD Abnormal Power Source Switching.
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-1917-2015. 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.