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 HVAD System Battery Charger The HeartWare HVAD System is Recalled by Heartware, Inc. Due to Potential for an HVAD System user to mistakenly...
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 HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Quantity: 5,489 devices total
Why Was This Recalled?
Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVAD Controller power port.
Where Was This Sold?
No affected devices distributed within the US. International distribution to Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, EGYPT, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Kazakhstan, Korea, Korea, Republic of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Taiwan, Province of China, Turkey, United Arab Emirates, United Kingdom, Vietnam.
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