FDA designates recall of ventricular assist device parts as class 1
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The FDA has designated Medtronic’s recall of two parts of a ventricular assist device system as a class 1 recall, the most serious kind.
The recall affects 4,924 devices (HeartWare HVAD pump outflow graft and outflow graft strain relief) distributed in the United States between March 1, 2018, and April 1, 2020, according to a safety alert from the agency.
These parts are used in a ventricular assist device system (HeartWare ventricular assist system) for patients with end-stage left ventricular HF who are at risk for death and awaiting cardiac transplant. This system can also be used for heart tissue recovery or destination therapy for those with no plans for transplantation.
The parts were originally recalled due to the outflow graft of the pump potentially tearing and the strain relief screw possibly breaking during assembly before implantation. These issues may not be noticed until during or after pre-implant assembly and attachment of the pump. Use of these products may lead to serious patient harm such as loss of consciousness, dizziness, fluid buildup around the heart and bleeding, in addition to death and additional medical procedures, according to the alert.
The tears and breaks associated with these parts have led to 92 complaints related to the pre-implant assembly process.
Medtronic distributed a letter April 3 alerting customers to review instructions for assembly for future implants, inspect the graft for possible tears after assembly and before implantation and to continue standard patient management during and immediately after the procedure, according to the alert.
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