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Heartware, Inc. recalls HeartWare HVAD Pump Kit, REF 1103
Recalled December 28, 2022 · FDA recall Z-0745-2023 · Heartware
Hazard
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. · FDA Class II
Units
5704 units
Sold at
Worldwide distribution.
Description
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.
Product
HeartWare HVAD Pump Kit, REF 1103
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →