medical Class I Updated 2021-04-14

Heartware, Inc. recalls Power Supply: 1. Medtronic HVAD Controller AC Adapter, Prod

Recalled Product

Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US 2. Medtronic HVAD Controller DC Adapter, Product Number: 1440


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide
Lot/Code Info: All lot codes
View official government recall

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