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Recall Observatory FDA recall evidence

Device product

HeartWare HVAD Pump Kit, REF 1104CA-CLIN

Z-0747-2023

November 29, 2022

Class II

Product summary

Firm
Heartware, Inc.
Event
Event 91281
Status
Ongoing
Classification
Class II
Quantity
6 units
Official record key
device-enforcement:Z-0747-2023

Official wording

Reason: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.

Code information: Serial Numbers: HW24101, HW24102, HW24103, HW24104, HW24755, HW24763

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.