HeartWare HVAD Pump Implant Kit — Class II medical device recall Z-1607-2014
Terminated recall by HeartWare Inc, reported 2014-05-21, distributed in AL, AZ, CA, CO, CT, DC, DE, FL…. Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unus
| Recall number | Z-1607-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartWare Inc, Miami Lakes, FL, United States |
| Recall initiated | 2014-04-16 |
| Classified | 2014-05-14 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2016-10-03 |
| Distributed | AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AR, AU, BE, BR, CA, CH, CL, CZ, DE, DO, EG, ES, FR, GB, GR, HK, HR, IL, IN, IT, JP, KR, LT, MY, NL, NO, PL, SG, SK, TR, TW, VE |
| Quantity | 32,349 |
| Model numbers | 1650, 1650-DE |
Product
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for recall
Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
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-1607-2014. 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.