HeartWare Ventricular Assist System — Class I medical device recall Z-1832-2017
Ongoing recall by Heartware, reported 2017-05-03, distributed nationwide. In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump D
| Recall number | Z-1832-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heartware, Miami Lakes, FL, United States |
| Recall initiated | 2017-03-10 |
| Classified | 2017-04-24 |
| Reported by FDA | 2017-05-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Quantity | 9 units |
Product
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Reason for recall
In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
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-1832-2017. 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.