Heartware, Inc. Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
Brand
Heartware, Inc.
Lot Codes / Batch Numbers
GTIN 00888707000147, All lot numbers in distribution
Products Sold
GTIN 00888707000147, All lot numbers in distribution
Heartware, Inc. is recalling Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 due to 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.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026