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On May 26, 2022, Medtronic reported financial results and disclosed that as a result of the Company’s need to improve its quality control system and its expectation that the MiniMed 780G model which management had repeatedly identified as crucial to future growth would not be approved in 2023, the Company expected revenues from its Diabetes Group to decline between 6% and 7% in the fiscal year 2023.
Back on December 15, 2021, Medtronic revealed that it had received a warning letter from the FDA regarding its Northridge, California facility. The Warning Letter followed an FDA inspection relating to the Company’s MiniMed 600 series recall, and focused on “the inadequacy of specific medical device quality system requirements . . . in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events.”
The Warning Letter further explained that Medtronic had known about the MiniMed quality issues for several years before the Company finally initiated the recall and that it failed to appropriately respond to complaints and report safety issues.
On this news, the price of Medtronic stock declined about 6% and lost several billion of its capitalization, seriously damaging investors.
Failure to Disclose,
Shock Event Date
26 May 2022