Medtronic Recalls Parts of Its HeartWare VAD System
The company has received reports of pump outflow graft tears and breaks of the strain relief screw, with four patient deaths.
Medtronic has issued an alert regarding specific parts of its HeartWare ventricular assist device (HVAD) system because of the risk of damage during assembly; the issue has been tied to four patient deaths. The US Food and Drug Administration has identified the action as a Class I recall, the most serious type.
According to an FDA alert released Thursday, Medtronic has received 92 complaints related to the pump assembly process, including 38 related to broken strain relief screws and 54 related to tears in the outflow graft. Two patient deaths were associated with the outflow graft tears, with an additional two deaths tied to complications following interventions for the issue.
“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,” the FDA alert notes.
Medtronic first alerted its customers to the potential for damage to the HVAD system during assembly in an “Important Medical Device Safety Alert” sent on April 3, 2020. The company is not pulling products from the market, and instead provided some recommendations for users: review steps for assembly and attachment of the outflow graft and strain relief, closely inspect the graft after assembly and before implantation to check for tears, and continue standard patient management during and immediately after implantation to look for the issue.
“Medtronic is working with the FDA for approval of a design change that is intended to reduce the risk of damage during the assembly of the outflow graft and strain relief and attachment onto the pump during the preimplant procedure,” the company said in its letter. “Medtronic will provide training on this design change after the necessary regulatory approvals are obtained.”
The recall, which covers 4,924 devices in the United States, applies to the following HVAD components (with model numbers): pump outflow graft (1125), pump implant kit (1103), and implant accessories kit (1153). Affected products were distributed between March 1, 2018, and April 1, 2020.
US Food and Drug Administration. Medtronic recalls HeartWare HVAD pump outflow graft and outflow graft strain relief due to risk of breaks and tears during set up. Published and accessed on: May 28, 2020.