Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
This recall is currently active, issued April 3, 2020. It was issued by Heartware, Inc..
- Company
- Heartware, Inc.
- Recall Initiated
- April 3, 2020
- Recall Number
- Z-2058-2020
- Quantity
- 20147 devices
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution
Lot / Code Info
All lots and serial numbers in distribution
Root Cause
Device Design
Action Taken
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.