Recall archive / FDA device enforcement
HeartWare HVAD Pump Kit, REF 1104CA-CLIN — FDA record Z-0747-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 29, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- HeartWare HVAD Pump Kit, REF 1104CA-CLIN
- 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.
- Classification
- Class II
- Recalling firm
- Heartware, Inc.
- Quantity
- 6 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0747-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial Numbers: HW24101, HW24102, HW24103, HW24104, HW24755, HW24763 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 28, 2022
- Recall initiation date
- Nov 29, 2022
- Center classification date
- Dec 21, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.