Recall Z-2058-2020 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
| Date | Apr 3, 2020 |
| Status | Open, Classified |
| Reason | The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. |
| Root cause | Device Design |
| Action | The firm disseminated a Medical Device Safety Alert by letter beginning on 04/03/2020. The notice explained he potential for damage that can occur during the procedure. Specifically, the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. The letter also provided additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure which was provided in Appendix A. |
| Quantity | 20147 devices |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.