For more than a year, Medtronic’s HeartWare Ventricular Assist Device (HVAD) breathing systems have faced an onslaught of recalls due to severe issues that can cause serious injury or even death to patients. Medtronic’s HVAD systems were regularly implanted in patients with severe heart failure to help pump blood from the heart to the rest of the body. The devices are used as a bridge to cardiac transplants in patients at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients who will not have a heart transplant.
June 2021
In June 2021, Medtronic stopped the sale and distribution of the HVAD breathing system due to the increased risk of mortality and neurological adverse events in patients using the device after a malfunction was uncovered. The malfunction caused the device to restart, fail to restart or delay working. There were over 100 complaints involving delay or failure to restart the pump that led to 14 deaths and 13 pump removals. Both of these issues may lead to serious injuries such as stroke, heart attack, worsening heart failure, or death. 4,620 devices were included in this recall and were distributed from August 30, 2016, through June 3, 2021.
However, at the time Medtronic stopped selling and distributing the devices, 4,000 devices were still implanted in patients. Since ceasing distribution of the devices in June 2021, Medtronic has voluntarily recalled certain systems and/or components due to a variety of issues.
April 2022
For instance, in April 2022, Medtronic issued a recall that the FDA classed as Class 1 for a welding defect that disrupted the internal pump in the system. Analysis of the devices showed moisture had entered the center of the pump which caused corrosion and the demagnetization of the device’s internal magnets. This can cause the pump to rotate incorrectly. The defect injured two patients and caused one death. The devices were distributed from October 11, 2006, through June 3, 2021.
June 2022
Additionally, in June 2022, another patient’s death prompted Medtronic to issue another recall that the FDA deemed to be Class 1. In this recall, batteries for the system stopped providing power or failed to hold a charge. The issue stems from another welding defect that impacted the internal components of the battery which caused the battery to malfunction by either no longer providing power to the device or preventing the battery from holding a charge.
How Goldenberg Lauricella Can Help YouIf you or a loved one were implanted with a Medtronic HVAD breathing system and suffered an injury or death due to device malfunction, contact the Minnesota Defective Medical Device Attorneys at Goldenberg Lauricella. Medical device lawsuits are complex, and our team has more than 35 years of experience providing our clients the Gold standard of advocacy. Contact us today for a free consultation.