Out of approximately the 22,000 HVAD pumps distributed through March 5, 2020, Medtronic had received 92 complaints related to the pre-implant assembly process and the associated outflow graft tears and strain relief screw damage. Complications related to outflow graft tears resulted in 54 complaints, including two deaths, resulting from peri-operative and post-operative bleeding. There were 38 complaints related to broken strain relief screws, with product damage identified prior or during the implant in 74 cases and post-implant in 18 cases. No harm related to damaged strain relief screws were yet reported. According to the FDA, the use of these defective products can cause dizziness, loss of consciousness, bleeding, fluid buildup around the heart, the need for additional medical procedures, and/or death.