Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use Recalled by HeartWare Inc Due to The affected clinical trial Controllers exhibit a higher...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact HeartWare Inc directly.
Affected Products
HeartWare Ventricular Assist System (HeartWare 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 HeartWare System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Quantity: 4,845
Why Was This Recalled?
The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About HeartWare Inc
HeartWare Inc has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report