Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - Recalled by HeartWare Inc Due to Patients and caregivers are instructed that if a...
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 HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Quantity: 32,349
Why Was This Recalled?
Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.
Where Was This Sold?
This product was distributed to 36 states: AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MD, MA, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY
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