February 4, 2026
Finance

Boston Scientific Reports Solid Q4 Results But Shares Decline Amid Safety Concerns

Medical Device Sales Growth Outpaces Estimates Despite Challenges Surrounding AXIOS Stent

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Summary

Boston Scientific Corporation delivered fourth-quarter financial results for 2025 largely in line with analyst projections, including adjusted earnings surpassing expectations and robust sales growth across key segments. However, shares faced downward pressure amid warnings from the U.S. Food and Drug Administration regarding deployment issues with its AXIOS stent systems, which have been linked to serious injuries and fatalities, prompting recalls and regulatory scrutiny.

Key Points

Boston Scientific’s Q4 2025 revenue modestly beat consensus and aligned with company guidance.
Adjusted earnings per share exceeded expectations, supported by solid growth in cardiovascular and MedSurg segments.
The company projects 2026 revenue growth and earnings consistent with market estimates.
Shares declined sharply due to safety issues with AXIOS stent systems under FDA review.

On Wednesday, Boston Scientific Corporation (NYSE:BSX) released its financial results for the fourth quarter of fiscal year 2025, demonstrating sales performance that met or edged past market expectations. The medical technology firm reported total revenues of $5.29 billion, marginally exceeding the consensus forecast of $5.28 billion and sitting well within the company's own revenue guidance range of $5.22 billion to $5.31 billion.

Adjusted earnings per share came in at 80 cents, outperforming analyst estimates of 78 cents and surpassing the company's guidance band of 77 to 79 cents per share. On a reported basis, sales clocked in with a 15.9% increase compared to the previous year, aligning comfortably inside management’s expected range of 14.5% to 16.5%. On an operational basis that excludes foreign exchange impacts and acquisitions, growth stood at 14.3%, while organic growth, which strips out the effects of currency and acquisitions, amounted to 12.7%, exceeding the anticipated 11% to 13% range.

The cardiovascular segment, a critical contributor to Boston Scientific's revenue mix, recorded sales of $3.48 billion, marking an 18.2% rise overall. Operational growth within this segment was 16.5%, with organic sales expanding by 16.1%. Notable sub-segments within cardiovascular included interventional Cardiology & Vascular Therapies, which grew organically by 7%, reaching $1.20 billion in sales. The Watchman device division saw impressive revenue gains of 29%, amounting to $535 million. Electrophysiology products registered a 35% increase to $890 million, and Cardiac Rhythm Management improved modestly by 1% to $587 million.

The Medical Surgical (MedSurg) segment contributed $1.81 billion in sales, up 11.7% overall. Operational growth here was 10.2%, while organic sales rose 6.5%. Within MedSurg, endoscopy led growth with a 10.1% sales increase to $760 million. The neuromodulation business grew 11.1% to $332 million, and urology products experienced a 13.8% rise, generating $717 million in sales.

Boston Scientific maintained a stable margin profile year over year, reporting an adjusted gross margin of 70.7% and an operating margin of 27.3%, essentially unchanged from prior periods.

Looking ahead to fiscal year 2026, Boston Scientific projected net sales growth between approximately 10.5% and 11.5% on a reported basis, and between 10% and 11% organically. The company anticipates full-year revenue to fall within a range of $22.18 billion to $22.38 billion. This forecast aligns closely with the consensus analyst revenue estimate of $22.37 billion. Adjusted earnings for the year are estimated at $3.43 to $3.49 per share, which is in line with the consensus forecast of $3.47 per share.

For the first quarter of 2026, Boston Scientific expects net sales growth of roughly 10.5% to 12% on a reported basis and 8.5% to 10% organically. This translates into expected sales between $5.13 billion and $5.22 billion, close to the consensus estimate of $5.20 billion. Adjusted earnings per share for the first quarter are forecast to range from 78 to 80 cents, near the 79-cent consensus figure. A company official indicated that foreign exchange rates are projected to contribute approximately 200 basis points to growth in the first quarter results.

Despite these strong financial metrics, Boston Scientific encountered a significant challenge stemming from safety concerns related to its AXIOS stent systems. In a December 19, 2025 communication, Boston Scientific directed customers to immediately cease use and distribution of specific AXIOS stents and electrocautery-enhanced delivery systems. The U.S. Food and Drug Administration (FDA) has confirmed awareness of this advisory due to reports indicating deployment and expansion difficulties with these devices.

The safety issues primarily involve devices used for endoscopic drainage of pancreatic pseudocysts and walled-off necrosis, in addition to gallbladder drainage for high-risk acute cholecystitis patients. Boston Scientific identified that some AXIOS systems exhibited increased challenges during stent deployment procedures, though this problem does not impact devices already implanted successfully.

As of December 23, 2025, the company had documented 167 serious injuries and three deaths associated with the malfunctioning devices. In response, Boston Scientific directed healthcare providers to remove all affected products from their inventories and return them. The FDA is actively evaluating the situation and plans to provide updates as further information emerges.

The news triggered a pronounced reaction in Boston Scientific's stock price as shares fell sharply by 15.76% to $77.18 at the time of the Wednesday market close. This decline pushed the stock to a new 52-week low, according to market data services.


Key Points:

  • Boston Scientific’s Q4 2025 revenue of $5.29 billion narrowly surpassed consensus estimates and matched company guidance.
  • Adjusted earnings per share came in at 80 cents, beating analyst expectations and management forecasts.
  • Strong growth was recorded across cardiovascular and MedSurg segments with notable increases in Watchman, electrophysiology, and urology categories.
  • The company’s forecast for 2026 revenue and earnings remains broadly consistent with market consensus.

Risks and Uncertainties:

  • Safety concerns linked to the AXIOS stent and related delivery systems have led to recalls and FDA scrutiny, posing potential reputational and financial risks.
  • The reported 167 serious injuries and three patient deaths related to AXIOS devices highlight serious product liability and regulatory compliance challenges.
  • Ongoing FDA investigations and product removals may impact future sales, especially in endoscopy and related therapeutic areas.
  • Foreign exchange rate fluctuations, while currently projected to provide a benefit, could alternatively impact future results negatively.
Risks
  • Deployment and expansion problems with AXIOS stents have led to product recalls and FDA scrutiny.
  • Reported injuries and deaths associated with the devices raise significant liability concerns.
  • Regulatory review and product removals may dampen sales in key therapeutic areas.
  • Uncertainty in foreign exchange impacts could alter forecasted financial performance.
Disclosure
Education only / not financial advice
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