Drug recall
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
FDA recall event 85397 · Class I · Heartware, Inc.
Key facts
| Event ID | 85397 |
|---|---|
| Recall numbers | Z-2055-2020, Z-2056-2020, Z-2057-2020, Z-2058-2020, Z-2059-2020 |
| Recalling firm | Heartware, Inc. |
| Product type | Devices |
| Products | Heartware HVAD Pump Implant accessories, Product (REF) Number 1153, Heartware HVAD Pump Implant Kit, Product (REF) Number 1103, Heartware HVAD Pump Implant Kit, Product (REF) Number 1104, Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP, Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Apr 3, 2020 |
| Report date | Jun 3, 2020 |
| City | Miami Lakes |
| State | FL |
| Country | United States |
| FEI number | 3007042319 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: