Medtronic, according to FDA, said the outflow graft of the HVAD Pump could 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.
Medtronic said using the affected products could result in serious patient harm, including dizziness, loss of consciousness, bleeding, fluid buildup around the heart, additional medical procedures and death, according to the FDA notice of the recall.
So far, the company has received 92 complaints related to the device, according to FDA. Medtronic reported four deaths related to the device in a physician letter, including 2 deaths related to outflow graft tears and 2 deaths related to subsequent complications following outflow graft intervention.
Medtronic sent a medical device safety alert to all affected customers. The company recommends reviewing the steps listed in the device’s appendix for assembly and attachment, closely inspecting the graft after assembly and before implantation, practicing standard peri-operative and immediate post-operative patient management.
The recall affects devices distributed March 1, 2018 to April 1, 2020 and includes 4,924 devices recalled in the U.S.
The HeartWare HVAD sSystem helps the heart deliver blood to the rest of the body. The device previously faced a Class I recall in June 2018 over issues with unexpected power source switching.
This story has been updated to include the number of deaths in the letter from Medtronic.