Recall Z-0746-2023— Heartware, Inc.
Class II · Ongoing
Class II FDA medical device recall by Heartware, Inc., initiated 2022-11-29. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartWare HVAD Pump Kit, REF 1104. 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..
- Recalling firm
- Heartware, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-29
- Firm location
- Miami Lakes, FL, United States
Product description
HeartWare HVAD Pump Kit, REF 1104
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.