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 Controller Product Usage: For use as Recalled by Heartware, Inc. Due to Loose connector ports in controller body.
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 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
Quantity: 4235 Worldwide, 7272 units in U.S.
Why Was This Recalled?
Loose connector ports in controller body.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Heartware, Inc.
Heartware, Inc. has 60 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report