Medtronic (NYSE:MDT) is recalling its HeartWare HVAD pump implant kit because the device may fail to start, restart, or have a delay in restarting after the pump was stopped, the FDA announced today.
These delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations, the agency said. If the device has delays or fails to start or restart, this could cause serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death.
The company has received 26 complaints about this device issue, including 19 serious injuries and eight cases of patients who had a life-threatening event but recovered without long-term effects. Two deaths have been reported, and the FDA assigned it Class I designation, the most serious type of recall.
Medtronic notified affected customers in December 2020, with instructions on next steps. The recall covers three lots of HeartWar pump implant kits with model numbers PUMP 1103, PUMP 1104 and PUMP 1104JP. In the U.S., the recall covers 506 pumps worldwide, including 157 in the U.S.
This issue does not affect the pump while it is running, according to Medtronic. The risk exists when the pump is stopped, for example, during a controller exchange, and then attempting to restart the pump, company spokesperson Tracy McNulty told MassDevice in an email.
The HeartWare HVAD system helps the heart deliver blood to the rest of the body. This recall is just the latest for Medtronic’s HeartWare, which was implicated in four deaths in May 2020 due to problems with the device’s outflow graft.
The device previously faced a Class I recall in June 2018 over issues with unexpected power source switching.
This article has been updated with information from Medtronic.