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Recall Observatory FDA recall evidence

Device 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

Z-1337-2021

February 26, 2021

Class I

Product summary

Firm
Heartware, Inc.
Event
Event 87446
Status
Ongoing
Classification
Class I
Quantity
17992 units (8054 US)
Official record key
device-enforcement:Z-1337-2021

Official wording

Reason: 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.

Code information: All lot codes

Distribution pattern: Worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.