FDA Class I Recall: Medtronic HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain
Medtronic is recalling their HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief because the outflow graft of the HVAD Pump may tear and the strain relief screw may break during assembly prior to implant but might not be observed until during or after the pre-implant pump assembly and attachment to the HVAD pump.
The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.
The use of the affected products may cause serious patient harm including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death.
Medtronic has received 92 complaints related to the pre-implant pump assembly process, which includes both the strain relief screw breaking and outflow graft tears.
Recalled Product:
HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief
Model Numbers:
HVAD Pump Outflow Graft: 1125
HVAD Pump Implant Kit: 1103
HVAD Implant Accessories Kit: 1153
Distribution Dates: March 1, 2018 to April 1, 2020
Devices Recalled in the U.S.: 4,924
Date Initiated by Firm: April 3, 2020
The HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief, which are parts of the HeartWare Ventricular Assist Device (HVAD) System, help the heart deliver blood to the rest of the body. The HVAD system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients where new transplants are not planned.
