SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Medtronic Plc - MDT

NEW YORK, Oct. 3, 2022

The investigation concerns whether Medtronic and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. 

[Click here for information about joining the class action] 

On December 15, 2021, Medtronic disclosed receipt of a warning letter from the U.S. Food and Drug Administration ("FDA") regarding its Northridge, California facility (the "Warning Letter").  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.  As a result of the Warning Letter—including the resulting uncertainty about FDA approval of the MiniMed 780G and other products in Medtronic's diabetes operating unit (the "Diabetes Group")—Medtronic lowered its guidance for its Diabetes Group, now projecting that Diabetes Group product revenues would decline in the mid-single digits range for fiscal year 2022.  

On this news, Medtronic's stock price fell $6.75 per share, or approximately 6%, to close at $104.94 per share on December 15, 2021. 

Then, on May 26, 2022, Medtronic reported its financial results for the fourth quarter and full year of fiscal year 2022 and provided guidance for fiscal year 2023.  Notably, the Company disclosed that due to its need to improve its quality control system and its expectation that the MiniMed 780G model would not be approved in 2023, the Company expected revenues from its Diabetes Group to decline between 6% and 7% in fiscal year 2023.