What the changes say
- Diabetes separation is a major new execution risk: MiniMed sold approximately 10% publicly while Medtronic retains approximately 90%.
What changed since the prior 10-K
New
- NewBusiness and Operational Risks
Our success depends on our ability to differentiate our products and successfully execute and scale emerging technologies
Growth depends on executing and scaling multiple differentiated products and technology platforms, including regulatory approval, manufacturing readiness, and market adoption.
- NewLegal and Regulatory Risks
could delay or reduce adoption, limit utilization, or otherwise have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for them
Patent disputes or failure to protect intellectual property could cause damages, royalties, injunctions, or limits on selling current and future products.
- NewLegal and Regulatory Risks
We are subject to litigation, claims, investigations, and regulatory proceedings, which are inherently unpredictable and could materially adversely affect our business, results of operations, financial condition, and cash flows
Product liability, commercial, tax, securities, employment, environmental, competition, and regulatory proceedings may be costly, disruptive, and encouraged by litigation funding.
- NewRisks Relating to the Proposed Separation of Our Diabetes Business
The ongoing separation of our Diabetes Business could be delayed, may not be completed as currently contemplated, and could materially adversely affect our business, results of operations, financial condition, and cash flows
The MiniMed separation may be delayed or fail to proceed as planned; Medtronic currently retains approximately 90% after MiniMed’s 10% IPO.
- NewRisks Relating to Our Jurisdiction of Incorporation
We are incorporated in Ireland, and our jurisdiction of incorporation may subject us to risks that could adversely affect our business and holders of our securities
Irish incorporation may make U.S. judgments and securities-law claims harder to enforce against Medtronic or its directors and officers.
Dropped
- DroppedBusiness and Operational Risks
Our success depends on our ability to differentiate our product and keep pace with emerging technologies
- DroppedBusiness and Operational Risks
We 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
Ability to differentiate products and keep pace with emerging technologies.
- DroppedRisks Relating to Our Jurisdiction of Incorporation
We 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
Reworded
- 90% rewrittenLegal and Regulatory Risks
The outcome of Medtronic, Inc.'s U.S. tax litigation could have a material adverse impact on our financial condition
The tax appeal was remanded to the Tax Court in September 2025 for additional proceedings, replacing the prior description of pending appellate proceedings.
- 88% rewrittenLegal and Regulatory Risks
Healthcare policy changes may have a material adverse effect on us
Healthcare reforms now expressly increase the importance of competing on outcomes as well as cost.
- 77% rewrittenBusiness and Operational Risks
Our 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
- 71% rewrittenLegal and Regulatory Risks
Our failure to comply with laws and regulations relating to reimbursement of healthcare goods and services, or changes to such laws, coverage policies, and payment practices, may subject us to penalties and adversely impact demand, our reputation, business, results of operations, financial condition, and cash flows
The risk now specifically identifies coverage decisions, prior authorization, utilization management, payment variability, procedure volumes, and patient access.
Was: Our 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
- 69% rewrittenBusiness and Operational Risks
We have debt obligations that create risk
- 55% rewrittenBusiness and Operational Risks
We operate in a highly competitive industry and we may be unable to compete effectively
The competitive-threat example changed from reprocessed or generic products to reprocessed or competitive devices after patent protection ends.
- 48% rewrittenLegal and Regulatory Risks
We are subject to a variety of risks associated with global operations that could adversely affect our profitability and operating results
The global-risk list was reordered to place trade measures, sanctions, export controls, and tariffs before healthcare reform; no new substantive threat is stated.
- 45% rewrittenLegal and Regulatory Risks
We are subject to environmental laws and regulations and the risk of environmental liabilities, violations and litigation
- 42% rewrittenLegal and Regulatory Risks
Consolidation in the healthcare industry and the growing prevalence of ASCs could have an adverse effect on our revenues and results of operations
Was: Consolidation 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
- 28% rewrittenRisks Relating to Our Jurisdiction of Incorporation
As an Irish public limited company, we are required to obtain shareholder approval for certain capital structure decisions, which may limit our flexibility to manage our capital structure
Was: As an Irish public limited company, certain capital structure decisions require shareholder approval, which may limit Medtronic’s flexibility to manage its capital structure
- 25% rewrittenLegal and Regulatory Risks
Changes 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
- 24% rewrittenLegal and Regulatory Risks
Healthcare industry cost-containment measures could result in reduced sales of our medical devices and medical device components
All 32 risk factors
Headings as the filing states them, in filing order.
Business and Operational Risks
- 01We operate in a highly competitive industry and we may be unable to compete effectively55% rewritten
- 02Our success depends on our ability to differentiate our products and successfully execute and scale emerging technologiesNew
- 03Reduction or interruption in supply or other manufacturing difficulties may adversely affect our manufacturing operations and related product sales
- 04Our 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 successful77% rewritten
- 05We have debt obligations that create risk69% rewritten
- 06Public 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
Legal and Regulatory Risks
- 07We 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
- 08Quality 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
- 09Our failure to comply with laws and regulations relating to reimbursement of healthcare goods and services, or changes to such laws, coverage policies, and payment practices, may subject us to penalties and adversely impact demand, our reputation, business, results of operations, financial condition, and cash flows71% rewritten
- 10could delay or reduce adoption, limit utilization, or otherwise have an impact on the acceptance of and demand for our products and the prices that our customers are willing to pay for themNew
- 11Healthcare policy changes may have a material adverse effect on us88% rewritten
- 12We are subject to litigation, claims, investigations, and regulatory proceedings, which are inherently unpredictable and could materially adversely affect our business, results of operations, financial condition, and cash flowsNew
- 13Changes 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 flows25% rewritten
- 14The outcome of Medtronic, Inc.'s U.S. tax litigation could have a material adverse impact on our financial condition90% rewritten
- 15The failure to comply with anti-corruption laws could materially adversely affect our business and result in civil and/or criminal sanctions
- 16Laws and regulations governing international business operations could adversely impact our business
- 17Our insurance program may not be adequate to cover future losses
- 18Climate change or legal, regulatory or market measures to address climate change may materially adversely affect our financial condition and business operations
- 19We are subject to environmental laws and regulations and the risk of environmental liabilities, violations and litigation45% rewritten
- 20We are subject to risks related to our sustainability practices and initiatives
- 21Changes 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
- 22We are subject to a variety of risks associated with global operations that could adversely affect our profitability and operating results48% rewritten
- 23Consolidation in the healthcare industry and the growing prevalence of ASCs could have an adverse effect on our revenues and results of operations42% rewritten
- 24Healthcare industry cost-containment measures could result in reduced sales of our medical devices and medical device components24% rewritten
- 25The continuing development of many of our products depends upon us maintaining strong relationships with healthcare professionals
- 26Market disruptions resulting in diminished liquidity, or strikes or other work stoppages by healthcare professionals or staff, could adversely affect our revenues, results of operation, or financial condition
Risks Relating to the Proposed Separation of Our Diabetes Business
- 27The ongoing separation of our Diabetes Business could be delayed, may not be completed as currently contemplated, and could materially adversely affect our business, results of operations, financial condition, and cash flowsNew
Risks Relating to Our Jurisdiction of Incorporation
- 28We are incorporated in Ireland, and our jurisdiction of incorporation may subject us to risks that could adversely affect our business and holders of our securitiesNew
- 29A 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
- 30As an Irish public limited company, we are required to obtain shareholder approval for certain capital structure decisions, which may limit our flexibility to manage our capital structure28% rewritten
- 31In 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
- 32Our shares received by means of a gift or inheritance could be subject to Irish capital acquisitions tax
Other Medtronic 10-Ks
- FY2025 10-K risk factors30 risks
Medtronic faces intense global competition, strict medical device regulations, and pricing pressures from consolidating healthcare systems. The company relies heavily on ongoing R&D, product differentiation, and maintaining strong relationships with healthcare professionals. Operations are subject to complex international laws, tax uncertainties, and Irish legal requirements.
Filed Jun 20, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.