Known Identifiers & Locations
FEI Numbers
3007042319
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (2)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0005-2017 |
HeartWare Ventricular Assist System Controller
Product Usage:
For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Reason: Loose connector ports in controller body.
|
2016-06-08 |
Terminated
|
View Details
|
| Z-0006-2017 |
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX.
Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Reason: Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
|
2016-08-17 |
Open, Classified
|
View Details
|
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