HeartWare Ventricular Assist System — Class I medical device recall Z-0006-2017
Ongoing recall by HeartWare, Inc, reported 2016-10-19, distributed in AL, AR, AZ, CA, DC, FL, IL, IN…. Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance re
| Recall number | Z-0006-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HeartWare, Inc, Miami Lakes, FL, United States |
| Recall initiated | 2016-08-17 |
| Classified | 2016-10-13 |
| Reported by FDA | 2016-10-19 |
| Distributed | AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, WI |
| Countries outside the US | AR, BR, CA, CL, CO, HK, IL, IN, KR, KW, LB, MY, NZ, RS, SA, SG, TR, TW, VN, ZA |
| Quantity | 344 pumps |
| Reason classes | foreign material |
| Model numbers | 1103, 1104XX |
Product
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason for recall
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
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-0006-2017. 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.