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: HeartWare Battery Recalled by Heartware, Inc. Due to Heartware Ventricular Assist System Battery Cell experiencing premature...
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: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.
Quantity: 18, 631
Why Was This Recalled?
Heartware Ventricular Assist System Battery Cell experiencing premature depletion.
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