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Heartware, Inc. Recall 91281

Description: HeartWare Model 1100

Heartware, Inc. Recall 91281 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0742-2023
Event ID91281
Event DescriptionHeartWare Model 1100
Product TypeDevices
DistributionWorldwide distribution.
Quantity45 units
Recall ReasonOver 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.
Device Classification20221228
Device Code InfoSerial Numbers: HW001, HW012, HW016, HW017, HW023, HW025, HW028, HW044, HW045, HW046, HW047, HW049, HW050, HW051, HW061, HW064, HW083, HW084, HW086, HW091, HW094, HW104, HW105, HW108, HW109, HW110, HW114, HW115, HW116, HW119, HW126, HW127, HW129, HW130, HW131, HW138, HW139, HW143, HW146, HW147, HW153, HW156, HW161, HW170, HW181
Center Classification Date20221221
Recall Initiation Date20221129
Recalling FirmHeartware, Inc.
Initial Notification Letter
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