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 Device (HVAD) System Batteries Recalled by Heartware, Inc. Due to Battery performance issues. Battery electrical faults render it...
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 Device (HVAD) System Batteries, Product Number 1650DE
Quantity: 19616 batteries
Why Was This Recalled?
Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Heartware, Inc.
Heartware, Inc. has 60 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report