HVAD Ventricular Assist Device Instructions Updated for Controller Alarm and Lifespan
Heartware is updating instructions for the HVAD ventricular assist device to clarify controller fault alarm conditions and component useful life guidance for 126 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a risk-of-harm product (implanted ventricular assist device) where no injuries have been reported. The recall addresses instructional clarity regarding critical device functions. Per the severity rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
The HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model 1205, is subject to a Class II recall affecting 126 units distributed worldwide. Heartware, Inc., the manufacturer, is providing updated instructions for use (IFU) and patient manual materials.
The updates are intended to clarify the conditions under which the HVAD controller fault alarm may sound and to provide recommended troubleshooting actions. The updates will also clarify instructions relating to the useful life of HVAD system components.
Patients who have received the HVAD implant should consult with their healthcare provider regarding any questions about these updated instructions or device operation.
The recalled product
- Product
- HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
- Manufacturer
- Heartware, Inc.
- Hazard
- unclear-instructions
- device-alarm-conditions
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial numbers: HW1412
- HW1413
- HW1416
- HW1433
- HW1435
- HW1490
- HW1493
- HW1495
- HW1496
- HW1593
- HW1599
- HW1641
- HW1661
- HW1662
- HW1663
- HW1664
- HW1695
- HW1696
- HW1698
- HW1699
Distribution
Distribution scope not specified by the agency.
Related recalls
Same category
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27