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 (HVAD). Catalog #'s US: 1101 and Recalled by HeartWare Inc Due to HeartWare has received complaints relating to damage or...
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 (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
Quantity: 3,747 currently implanted worldwide
Why Was This Recalled?
HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.
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