The Action alleges that, throughout the Class Period, Defendants misled investors by failing to disclose that: (a) the Novum LVP suffered systemic defects that caused widespread malfunctions, including underinfusion, overinfusion, and complete non-delivery of fluids, which exposed patients to risks of serious injury or death; (b) Baxter was notified of multiple device malfunctions, injuries, and deaths from these defects; (c) Baxter’s attempts to address these defects through customer alerts were inadequate remedial measures, when design flaws persisted and continued to cause serious harm to patients; (d) as a result, there was a heightened risk that customers would be instructed to take existing Novum LVPs out of service and that Baxter would completely pause all new sales of these pumps; and (e) based on the foregoing, Baxter’s statements about the safety, efficacy, product rollout, customer feedback and sales prospects of the Novum LVPs were materially false and misleading.