Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
- Company
- Heartware, Inc.
- Recall Initiated
- April 3, 2020
- Recall Number
- Z-2059-2020
- Quantity
- 560 units
- Firm Location
- Miami Lakes, FL
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
GTIN 00888707000147, All lot 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.