FDA-Device2022-12-28Class II
HeartWare HVAD Pump Kit, REF MCS1705PU
Heartware, Inc.
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.
Sold states
Worldwide distribution.
Affected count
146 units
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
Products
HeartWare HVAD Pump Kit, REF MCS1705PU
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0750-2023Don't want to check this manually?
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