What is The Medtronic HeartWare HVAD System?
The Medtronic HeartWare HVAD System (“HeartWare” or “HVAD”) is a left ventricular assist device used to treat patients who are awaiting a heart transplant (bridge-to-transplant) and patients who are in end-stage heart failure and not eligible for or are too sick to receive a heart transplant (destination therapy). The HeartWare system includes a mechanical pump implanted in the space around the heart (pericardium), a controller that controls the speed and function of the pump, a tube inserted into the heart to drain the blood, and a tube inserted in the aorta for the blood that is being pumped. The controller remains outside the patient’s body and is connected to the pump by a flexible tube that passes through the patient’s skin. The controller is powered either by batteries or a power supply that can be connected to a standard electrical power outlet.
The HeartWare System has been RECALLED by Medtronic. The FDA has identified this as a Class 1 recall, which is the most serious type of medical device recall by the FDA and indicates that use of the device could cause severe injury or death to patients.
The History of the HeartWare Recalls
The Internal Pump
On November 19, 2020, Medtronic initiated a Class 1 Recall of HeartWare Ventricular Assist Devices (“HVAD”) pumps manufactured with impellers from a subset of lots that were failing to start, restart or experiencing a delay in restarting “at a rate substantially higher than pump[s] in the overall population.” In a December 2020 letter to physicians, Medtronic explained what it meant by “substantially higher”: the failure rate among the recalled pumps was 5.2% compared to a failure rate in the general pump population of 0.087%. Medtronic indicated that pump failure could result in cardiac arrest, reoperation to replace the pump, and patient death. In a May 2021 letter to physicians, Medtronic reporter additional cardiac arrests, reoperations, and patient deaths during the past five months as a result of the HeartWare pump stopping and failing to restart.
On June 3, 2021, Medtronic issued a Class 1 recall of all HeartWare pumps, telling doctors to “immediately stop” implanting its HVAD because of increased neurologic adverse events associated with the internal pump, and an increased risk of death due to sudden pump stoppage and failing to restart. Medtronic reported that there were more than 100 complaints involving a delay or failure of the HeartWare pump to restart, which led to 14 deaths and 13 pump removals.
In an April 2022 letter to physicians, Medtronic provided information from its inspection of returned pumps that stopped and failed to restart. Although pump thrombosis was initially suspected, Medtronic engineers observed “wear marks” on the inside of the pumps during inspection indicating that the pump impeller was not rotating concentrically and was contacting the center post during its rotation. Medtronic concluded that this non-concentric rotation of the impeller “was caused by a weld defect that allowed moisture into the center post and corrode the magnets that keep the impeller rotating concentrically.” Medtronic advised doctors to watch for certain signs and symptoms that could resemble pump thrombosis (but actually represent the consequences of magnet corrosion by moisture infiltration), including transient power spikes and “High Watt” alarms.
The External Batteries
In a June 2022 letter to doctors and VAD coordinators, Medtronic disclosed two defects in its HeartWare batteries: 1) a welding defect that can cause the battery to fail to deliver power; and 2) an interaction between the battery software and the battery circuit board that cause causes electrical faults within the batteries (i.e. a “short circuit”). As a result of these battery defects, on June 28, 2022 Medtronic recalled all HeartWare batteries because of the increased risk of electrical faults causing the batteries to fail and leading to HVAD pump stoppage.
Contact Meshbesher & Spence for a Free Consultation
If you or a loved one was implanted with a Medtronic HeartWare HVAD pump and suffered serious injury or death resulting from:
- the HVAD pump stopping and failing to restart; or
- complications during surgery to replace a defective HVAD pump with a new pump; or
- the HVAD pump failing to provide adequate hemodynamic support as a result of a pump defect (often accompanied by transient power spikes and “High Watt” alarms)
please contact attorney Tony Nemo at Meshbesher & Spence today. Your consultation is free, and you pay nothing until our Firm recovers fair compensation for you and your family.
