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) Recalled by HeartWare, Inc Due to Foreign Object Contamination
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), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Quantity: 344 pumps
Why Was This Recalled?
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
Where Was This Sold?
This product was distributed to 26 states: AL, AZ, AR, CA, FL, IL, IN, KY, LA, MA, MI, MN, MO, NE, NJ, NY, NC, OH, OK, PA, SC, TX, UT, VA, WI, DC
About HeartWare, Inc
HeartWare, Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report