The Complaint alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the company’s business and operations by failing to disclose that: (1) Medtronic’s product quality control systems were inadequate; (2) Medtronic had failed to comply with numerous regulations regarding risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events; (3) these failures increased the risk of regulatory investigation and action; (4) as a result of the company’s misconduct, the FDA would delay the approval of additional Medtronic MiniMed devices, including the MiniMed 780G; (5) these delays in product approvals, as well as the company’s need to improve its quality control systems, would negatively affect Medtronic’s financial performance and cause it to fall further behind its competitors; and (6) as a result of the foregoing, Defendants’ statements about the company’s business, operations, and prospects lacked a reasonable basis.