FDA-Device2021-04-14Class I
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Heartware, Inc.
Hazard
There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Sold states
Worldwide
Affected count
114,133 devices (66,613 US)
Manufactured in
14400 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1340-2021Don't want to check this manually?
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