Boston Scientific (BSX) risk factors, FY2024 10-K

Boston Scientific's FY2024 10-K, filed Feb 18, 2025, lists 26 risk factors. There is no earlier 10-K to compare against, so the most company-specific risks are listed below.

Risk factors listed
261 groups
Section length
12k wordsItem 1A

Boston Scientific's biggest risks in the FY2024 10-K

  • Boston Scientific relies heavily on continuous medical device innovation, global manufacturing, and complex regulatory approvals while managing $10.746 billion in debt and international exposure.

The risks most specific to Boston Scientific

  • We face intense competition and may not be able to keep pace with the rapid technological changes in the medical devices industry, which could have an adverse effect on our business, financial condition or results of operations

    We face intense competition and may not keep pace with rapid technological changes in the medical devices industry.

  • If we are unable to manage our debt levels, maintain investment grade credit ratings at the three ratings agencies, or if we experience a disruption in our cash flows, it could have an adverse effect on our cost of borrowing, financial condition or results of operations

    Our outstanding debt balance was $10.746 billion as of December 31, 2024, and failing to manage debt levels or maintain investment grade credit ratings could increase our borrowing costs.

  • We are subject to a number of market, business, financial, legal and regulatory risks and uncertainties with respect to our international operations that could have a material impact on our business, financial condition or results of operations

    International net sales accounted for 39 percent of our global net sales in 2024, exposing us to market, legal, and regulatory risks outside the U.S.

  • Business and Operational Risks

    Interruption of our supply chain or manufacturing operations, including resulting from natural disasters, public health crises, geopolitical developments or other events outside of our control, could adversely affect our results of operations and financial condition

    Manufacturing is concentrated in one or a few locations for any specific product, making us vulnerable to supply chain and operational interruptions.

  • Business and Operational Risks

    Disruptions in the supply of the materials and components used in manufacturing our products by third-party vendors or the sterilization of our products could adversely affect our results of operations and financial condition

    We rely on third-party vendors for the majority of our materials and components, some of which are purchased from single sources.

  • Business and Operational Risks

    We are subject to extensive and dynamic medical device regulation, which may impede or hinder the approval or sale of our products and, in some cases, may ultimately result in an inability to obtain approval of certain products or may result in the recall or seizure of previously approved products

    Our products and manufacturing processes are subject to extensive and rigorous regulation by the FDA under the FDC Act and comparable foreign agencies.

  • Business and Operational Risks

    Pending and future product liability claims and other litigation, including private securities litigation, stockholder derivative suits and contract litigation, may adversely affect our financial condition and results of operations or liquidity

    We face inherent risks of product liability claims and other litigation because many of our medical devices are designed to be implanted in the human body long-term.

  • Business and Operational Risks

    Any failure to meet regulatory quality standards applicable to our manufacturing and quality processes could have an adverse effect on our business, financial condition and results of operations

    Failure to meet FDA quality system regulation standards and pass periodic inspections could adversely affect our business and manufacturing processes.

All 26 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01Economic, Industry and Geopolitical Risks
  2. 02We face intense competition and may not be able to keep pace with the rapid technological changes in the medical devices industry, which could have an adverse effect on our business, financial condition or results of operations
  3. 03We may experience declines in market size, average selling prices for our products, medical procedure volumes and our share of the markets in which we compete, which may materially adversely affect our results of operations and financial condition
  4. 04significant market segments, which could have an adverse effect on our business, financial condition or results of operations
  5. 05Challenging domestic and international economic conditions could adversely affect our business, financial condition, cash flows and results of operations
  6. 06We are subject to a number of market, business, financial, legal and regulatory risks and uncertainties with respect to our international operations that could have a material impact on our business, financial condition or results of operations
  7. 07If we are unable to manage our debt levels, maintain investment grade credit ratings at the three ratings agencies, or if we experience a disruption in our cash flows, it could have an adverse effect on our cost of borrowing, financial condition or results of operations
  8. 08We may record future goodwill impairment charges related to one or more of our global reporting units or other intangible asset impairment charges, which could materially adversely impact our results of operations

Business and Operational Risks

  1. 09Failure to integrate acquired businesses into our operations successfully could adversely affect our business, financial condition and operating results
  2. 10We may not be successful in our strategy relating to future strategic acquisitions of, investments in, or alliances with, other companies and businesses
  3. 11We may not realize the expected benefits from our restructuring and optimization initiatives, our long-term cost savings programs may result in an increase in short-term expenses and our efforts may lead to unintended consequences
  4. 12Our future growth is dependent upon the development of new products and enhancement of existing products, which requires significant research and development, clinical trials and regulatory approvals, all of which may be very expensive and time-consuming and may not result in commercially viable products
  5. 13Interruption of our supply chain or manufacturing operations, including resulting from natural disasters, public health crises, geopolitical developments or other events outside of our control, could adversely affect our results of operations and financial condition
  6. 14Disruptions in the supply of the materials and components used in manufacturing our products by third-party vendors or the sterilization of our products could adversely affect our results of operations and financial condition
  7. 15We rely on the proper function, availability and security of information technology systems to operate our business and a cyber-attack or other breach of these systems could have a material adverse effect on our business, financial condition or results of operations
  8. 16Our business and operations are subject to risks related to climate change
  9. 17Our business could be negatively impacted by corporate social responsibility and sustainability matters
  10. 18If we are unable to attract or retain key talent, it could have an adverse effect on our business, financial condition and results of operations
  11. 19Health care policy changes may have a material adverse effect on our business, financial condition, results of operations and cash flows
  12. 20We are subject to extensive and dynamic medical device regulation, which may impede or hinder the approval or sale of our products and, in some cases, may ultimately result in an inability to obtain approval of certain products or may result in the recall or seizure of previously approved products
  13. 21Our products are continually subject to clinical trials and other analyses conducted by us, our competitors or other third parties, the results of which may be unexpected, or perceived as unfavorable by the market, and could have a material adverse effect on our business, financial condition or results of operations
  14. 22Changes in tax laws, unfavorable resolution of tax contingencies, or exposure to additional income tax liabilities could have a material impact on our financial condition, results of operations and/or liquidity
  15. 23We may not effectively be able to protect our intellectual property, systems, software-based products or other sensitive data, which could have a material adverse effect on our business, financial condition or results of operations
  16. 24Pending and future intellectual property litigation could be costly and disruptive to us
  17. 25Pending and future product liability claims and other litigation, including private securities litigation, stockholder derivative suits and contract litigation, may adversely affect our financial condition and results of operations or liquidity
  18. 26Any failure to meet regulatory quality standards applicable to our manufacturing and quality processes could have an adverse effect on our business, financial condition and results of operations

Other Boston Scientific 10-Ks

  • FY2025 10-K risk factors
    27 risks2 new1 dropped9 reworded

    Boston Scientific faces new tax dispute and patent infringement litigation risks while refining disclosures on facility capacity constraints and site-of-care procedure migration.

    Filed Feb 17, 2026

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.