What is Happening with Medtronic HeartWare System?
In December 2020 and May 2021, Medtronic issued Urgent Medical Device Communications to healthcare providers warning that a certain subset of its HeartWare pumps could fail to initially start, fail to restart after stopping, or experience a delay in restarting, which could result in cardiac arrest, reoperation, and patient death.
On June 3, 2021 the FDA issued a letter to healthcare providers advising that Medtronic had decided to stop the sale and distribution of the HeartWare system because of an “increased risk of neurological adverse events and mortality associated with the internal pump.” Specifically, the FDA said that there is a potential for the internal pump to stop, and if the pump should stop, it may delay restarting or fail to restart at all. 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. Because the potential for serious injury or death, health care providers were told that they should no longer implant the Medtronic HeartWare system in patients.
In April 2022, Medtronic issued an Urgent Medical Device Correction advising healthcare providers about complaints of pump thrombosis (blood clot within the pump) caused by a welding defect that allows moisture into the pump after implantation and cause corrosion. In May 2022, Medtronic issued an Urgent Medical Device Recall of certain HeartWare batteries after determining that a welding defect could cause the batteries to malfunction and no longer provide power to the internal pump. In June 2022, Medtronic issued yet another Urgent Medical Device Correction with further information about the welding defect, and new information about an interaction between the battery software and the battery circuit board that could cause electrical faults within the batteries.
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