THE UNITED STATES – A news story posted on cardiovascularbusiness.com reports that the U.S. Food and Drug Administration announced that medical device manufacturer, Medtronic, has initiated a recall of its “HeartWare Ventricular Assist Device (HVAD) pump implant kit, a part of the HeartWare HVAD System.” The FDA categorized the recall as a Class I recall, which is the most serious recall classification. Class I recalls are assigned when a product’s defect could cause injury or death.
The FDA’s announcement follows numerous accusations that Medtronic’s pump implant kits could “fail to initially start, restart, or have a delay in restarting after the pump was stopped.” So far, there are about 29 reports on file. The reports include two fatalities and 19 serious injuries.
According to the FDA, these “delays or failures to start or restart have occurred during preimplant testing, during the implant, or in a variety of post-implant situations.” The FDA also stated that when the medical device “delays or fails to start or restart,” the patient could die, suffer a heart attack, additional heart damage, or may need additional surgical procedures and hospitalizations.
This recall involves Medtronic HeartWare Ventricular Assist Device (HVAD) pump implant kits labeled as PUMP 1103, PUMP 1004, or PUMP 1104JP. The lots affected by this recall include 8721869-001-01, 8722375-001-01, and 8722375-002-02. All HeartWare Ventricular Assist Device kits were distributed from October 23, 2017, until April 30, 2020.
Medtronic first contacted affected customers in December of 2020. The company provided specific instructions for both patients and healthcare providers.
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