FDA Device recall Z-1832-2017
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an elect…
- FDA Device
- Class I
- ongoing
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class I recall of HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an elect… by Heartware, citing 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 commun….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1832-2017 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2017-03-10 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Heartware |
| Distribution | US |
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
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.
Identifiers
| code_info | Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1832-2017%22
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