FDA-Device2022-06-29Class I
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Medtronic Inc
Hazard
Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
Sold states
Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.
Affected count
429 batteries
Manufactured in
710 Medtronic Pkwy Mailstop Ls245, Minneapolis, MN, United States
Products
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1266-2022Don't want to check this manually?
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