Medtronic has recalled its HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief products, which are part of the HeartWare Ventricular Assist Device (HVAD) System. The system is used as a bridge to cardiac transplants in patients who are at risk of death due to end-stage left ventricular heart failure, heart tissue recovery or as destination therapy.
The product issue: The outflow graft of the HVAD Pump could tear, and the strain relief screw could break during assembly (but before implanted) and go unnoticed until during or after attachment to the HVAD pump. Medtronic has received 92 complaints related to the issue. Adverse effects include dizziness, bleeding, loss of consciousness, fluid buildup around the heart, more medical procedures and death. The FDA recall page does not mention any reported deaths as a result of the product issue.
The recall affects nearly 5000 HeartWare pump outflow graft and strain relief parts that were distributed between March 1, 2018 and April 1, 2020.