Heart Ware — Class II medical device recall Z-0067-2019
Terminated recall by Heartware, Inc., reported 2018-10-10. Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid i
| Recall number | Z-0067-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Inc., Miami Lakes, FL, United States |
| Recall initiated | 2018-08-28 |
| Classified | 2018-10-03 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2019-04-05 |
| Quantity | 17,275 units |
| Reason classes | labeling, packaging |
| Model numbers | 1403, 1407, 1420 |
Product
Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Reason for recall
Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.
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-0067-2019. 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.