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 Complaints with the HVAD Internal Controller Alarm Battery...
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. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure.
Quantity: 3,747 curently implanted
Why Was This Recalled?
Complaints with the HVAD Internal Controller Alarm Battery failures.
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