Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac Recalled by HeartWare Inc Due to Complaints with the HVAD Discolored and Cracked Driveline...
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) 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 in use
Why Was This Recalled?
Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath.
Where Was This Sold?
This product was distributed to 32 states: AL, AZ, CA, CO, CT, DE, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, DC
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