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Heartware, Inc. recalls Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Recalled April 14, 2021 · FDA recall Z-1340-2021 · Heartware
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. · FDA Class I
Units
114,133 devices (66,613 US)
Sold at
Worldwide
Description
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.
Product
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →