FDA – According to a news report on medtechdive.com, the FDA issued another Class I recall of Medtronic’s HeartWare HVAD ventricular assist device due to the potential for severe injuries or deaths. Medtronic has initiated a recall of 157 HVAD Pump Implant Kits sold in the U.S. after Medtronics receive complaints that a few of the devices have “failed to start or restart promptly.” Two patients have died as a result of the defect. The FDA currently has issued three Class I recalls concerning the HeartWare in the past 12 months. In 2020, there were five deaths linked to the medical device’s faults.
Due to the application of HeartWare devices, any issues concerning the device can have severe or deadly outcomes. Patients use the HeartWare because they have medical conditions that cause them to rely on the pump’s life-saving distribution of blood flow to the patient’s left ventricles and throughout the patient’s body. The HVAD Pump Implant system consists of an external controller and an implantable pump. Medtronic has initiated a recall of the pump’s implant part of the HeartWare due to 29 complaints about the product. Some of the implantable pump kits have failed to start or restart. Some of the implantable pump kits have only restarted after a long delay.
Some of the faults were detected when undergoing pre-implant testing. However, some of the medical devices were implanted and later proved to have the fault. The device’s failure to start or restart quickly can cause heart attacks, worsening heart failure, and deaths, according to the FDA.
The FDA is aware of 19 serious injuries, two deaths, and eight cases of patients suffering “life-threatening events but recovered without long-term effects.
The FDA reemphasized that the advice Medtronic distributed in its notice to healthcare professionals in 2020. Medtronic recommends “keeping the device’s controller connected to the driveline and at least one power source.” In addition, doctors use precautions when exchanging controllers since the pump could fail to restart.
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