FDA Device recall Z-2058-2020
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
- FDA Device
- Class I
- ongoing
- Published 2020-06-03
On 2020-06-03 the FDA classified a Class I recall of Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 by Heartware, citing the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2058-2020 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2020-04-03 |
| Published | 2020-06-03 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Heartware |
| Distribution | n/a |
Product
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Reason
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Identifiers
| code_info | All lots and serial numbers in distribution |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2058-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.