Medtronic (MDT) risk factors, FY2025 10-K

Business and Operational Risks

1. 01We operate in a highly competitive industry and we may be unable to compete effectively
2. 02Our success depends on our ability to differentiate our product and keep pace with emerging technologies
3. 03Reduction or interruption in supply or other manufacturing difficulties may adversely affect our manufacturing operations and related product sales
4. 04Public health crises have had, and may continue to have, an adverse effect on certain aspects of our business, results of operations, financial condition, and cash flows. The nature and extent of future impacts are highly uncertain and unpredictable
5. 05Our research and development efforts rely upon investments and investment collaborations, and we cannot guarantee that any previous or future investments or investment collaborations will be successful
6. 06The continuing development of many of our products depends upon us maintaining strong relationships with healthcare professionals
7. 07We have debt obligations that create risk
8. 08We also could experience negative effects on our business, results of operations, financial condition, and cash flows from acquisition-related charges, amortization of intangible assets and asset impairment charges

Legal and Regulatory Risks

1. 09We are subject to extensive and complex laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations
2. 10Quality problems have in the past and could in the future lead to recalls or safety alerts, product liability claims, reputational harm, adverse verdicts or costly settlements, and could have a material adverse effect on our business, results of operations, financial condition, and cash flows
3. 11Our failure to comply with laws and regulations relating to reimbursement of healthcare goods and services may subject us to penalties and adversely impact our reputation, business, results of operations, financial condition, and cash flows
4. 12Healthcare policy changes may have a material adverse effect on us
5. 13The failure to comply with anti-corruption laws could materially adversely affect our business and result in civil and/or criminal sanctions
6. 14Laws and regulations governing international business operations could adversely impact our business
7. 15Climate change, or legal, regulatory or market measures to address climate change may materially adversely affect our financial condition and business operations
8. 16We are subject to environmental laws and regulations and the risk of environmental liabilities, violations and litigation
9. 17We are subject to risks related to our sustainability practices and initiatives
10. 18Our insurance program may not be adequate to cover future losses
11. 19Changes in tax laws or exposure to additional income tax liabilities could have a material impact on our business, results of operations, financial condition, and cash flows
12. 20The outcome of Medtronic, Inc.'s U.S. tax litigation could have a material adverse impact on our financial condition

Risks Relating to Our Jurisdiction of Incorporation

1. 21We are incorporated in Ireland, and Irish law differs from the laws in effect in the U.S. and may afford less protection to holders of our securities
2. 22As an Irish public limited company, certain capital structure decisions require shareholder approval, which may limit Medtronic’s flexibility to manage its capital structure
3. 23A transfer of our shares, other than ones effected by means of the transfer of book-entry interests in the Depository Trust Company, may be subject to Irish stamp duty
4. 24In certain limited circumstances, dividends we pay may be subject to Irish dividend withholding tax and dividends received by Irish residents and certain other shareholders may be subject to Irish income tax
5. 25Our shares received by means of a gift or inheritance could be subject to Irish capital acquisitions tax
6. 26Changes in the prices of our goods and services, customer purchasing patterns and stocking dynamics, and/or inflationary costs may have a material adverse effect on our business, results of operations, financial condition, and cash flows
7. 27We are subject to a variety of risks associated with global operations that could adversely affect our profitability and operating results
8. 28Market disruptions resulting in diminished liquidity, or healthcare professional and staff strikes or other work stoppages, could adversely affect our revenues, results of operation, or financial condition
9. 29Consolidation in the healthcare industry and the growing prevalence of ambulatory surgery centers (ASCs) could have an adverse effect on our revenues and results of operations
10. 30Healthcare industry cost-containment measures could result in reduced sales of our medical devices and medical device components