Product News and Recalls

Medtronic Braces as Additional Problems Found with HeartWare Device

Medtronic sees reports of pump thrombosis with HVAD Heartware pumpAnyone familiar with the process of buying a pre-owned vehicle knows how important the test drive is. Not only is this the time when you get a feel for it and see how it handles, but it is also the purchaser’s chance to determine if the vehicle is running properly. Your ears listen to the engine for odd sounds, and you give the brakes a good solid press to make sure they’re functioning as they should be.

Apparently, no one at Medtronic has ever purchased a pre-owned vehicle. The company acquired medical device manufacturer HeartWare in 2015 in a deal worth some $1 billion while HeartWare was receiving significant attention from the FDA over the safety of its HVAD heart pump. The investigation led to two safety letters being issued by the FDA regarding the device. The events culminated with a Class I recall being issued by the agency in 2016, its most serious action reserved only for those situations where the continued use of the device or item in question could cause significant injury or death.

Six years later, the HeartWare HVAD unit continues to cause problems. Reports are now surfacing of patients experiencing pump thrombosis with the device due to a potential welding defect. Three reports have been received so far of units making odd sounds, while diagnostics on the devices show evidence of power surges. Patients experienced light-headedness and dizziness as a result, and the lack of blood circulation also led to an increased risk of blood clotting. Devices involved in the incidents were manufactured between December 2017 and May 2018.

Over 3,000 patient deaths have been attributed to the HeartWare device, with some cases involving patients’ families watching helplessly as their loved ones collapsed to the ground and began vomiting blood. One case was so severe that an autopsy showed visible charring on the patient’s heart at the site of the implant from the device short-circuiting in their chest.