Boston Scientific Initiates Recall of AXIOS Stents Due to Serious Complications
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 4 days ago
0mins
Should l Buy BSX?
Source: Benzinga
- Product Recall: Boston Scientific has initiated a recall of AXIOS stents and Electrocautery-Enhanced Delivery Systems due to deployment complications linked to 167 serious injuries and three deaths, prompting an immediate halt to their use and distribution.
- FDA Notification: In compliance with the U.S. Food and Drug Administration (FDA), the company notified affected customers on December 19, 2025, advising them to cease using specific devices and to remove remaining inventory to ensure patient safety.
- Risk Assessment: The recall stems from increased reports of complications during stent deployment and expansion, which may prolong procedures and necessitate device replacement, thereby elevating surgical risks for patients.
- Follow-Up Care: Despite the issues, patients with successfully implanted AXIOS stents can continue standard follow-up care, with Boston Scientific emphasizing that the stents should only be used in accordance with their approved Instructions for Use.
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Analyst Views on BSX
Wall Street analysts forecast BSX stock price to rise
22 Analyst Rating
22 Buy
0 Hold
0 Sell
Strong Buy
Current: 76.850
Low
94.00
Averages
108.14
High
132.00
Current: 76.850
Low
94.00
Averages
108.14
High
132.00
About BSX
Boston Scientific Corporation is a global developer, manufacturer and marketer of medical devices that are used in a range of interventional medical specialties. The Company's MedSurg segment includes Endoscopy, Urology, and Neuromodulation. Its Endoscopy business develops and manufactures devices to diagnose and treat a range of gastrointestinal conditions with less-invasive technologies. Its Urology business develops and manufactures devices to treat various urological conditions for both male and female anatomies, including kidney stones, benign prostatic hyperplasia, prostate cancer, erectile dysfunction, and incontinence. Its Neuromodulation business develops and manufactures devices to treat various neurological movement disorders and manage chronic pain. Its Cardiovascular segment includes Cardiology and Peripheral Interventions. The Cardiology includes interventional cardiology therapies, watchman, cardiac rhythm management, and electrophysiology.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Boston Scientific Initiates Recall of AXIOS Stents Due to Serious Complications
- Product Recall: Boston Scientific has initiated a recall of AXIOS stents and Electrocautery-Enhanced Delivery Systems due to deployment complications linked to 167 serious injuries and three deaths, prompting an immediate halt to their use and distribution.
- FDA Notification: In compliance with the U.S. Food and Drug Administration (FDA), the company notified affected customers on December 19, 2025, advising them to cease using specific devices and to remove remaining inventory to ensure patient safety.
- Risk Assessment: The recall stems from increased reports of complications during stent deployment and expansion, which may prolong procedures and necessitate device replacement, thereby elevating surgical risks for patients.
- Follow-Up Care: Despite the issues, patients with successfully implanted AXIOS stents can continue standard follow-up care, with Boston Scientific emphasizing that the stents should only be used in accordance with their approved Instructions for Use.
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Boston Scientific Initiates Recall of AXIOS Stents Due to Serious Complications
- Product Recall: Boston Scientific has initiated a recall of AXIOS stents and Electrocautery-Enhanced Delivery Systems due to deployment complications linked to 167 serious injuries and three deaths, prompting an immediate halt to their use and distribution.
- FDA Notification: In compliance with the U.S. Food and Drug Administration (FDA), the company notified affected customers on December 19, 2025, advising them to cease using specific devices and to remove remaining inventory to ensure patient safety.
- Risk Assessment: The recall stems from increased reports of complications during stent deployment and expansion, which may prolong procedures and necessitate device replacement, thereby elevating surgical risks for patients.
- Follow-Up Care: Despite the issues, patients with successfully implanted AXIOS stents can continue standard follow-up care, with Boston Scientific emphasizing that the stents should only be used in accordance with their approved Instructions for Use.
See More
Penumbra Reports Strong 2025 Financial Results
- Significant Revenue Growth: Total revenue for Q4 2025 reached $385.4 million, a 22.1% increase from Q4 2024, with the U.S. market contributing 77.6%, indicating strong domestic performance.
- Strong Product Sales: Sales of global thrombectomy products amounted to $254.7 million, up 15.7%, primarily driven by a 12.4% increase in the U.S. market, reflecting sustained demand in key product lines.
- Improved Gross Margin: The gross margin for Q4 2025 was 68.0%, up from 66.8% in Q4 2024, attributed to product mix optimization and enhanced production efficiency, signaling potential future profitability improvements.
- Controlled Operating Expenses: Although R&D expenses slightly increased to $21.8 million, total operating expenses as a percentage of revenue decreased to 52.6%, demonstrating the company's ability to effectively manage costs during expansion.
See More
Investigation into Boston Scientific for Securities Fraud Claims
- Investigation Launched: Pomerantz LLP is investigating Boston Scientific and its executives for potential securities fraud and other unlawful business practices, aiming to protect investor rights and seek legal remedies.
- Disappointing Earnings: On February 4, 2026, Boston Scientific reported its fourth-quarter 2025 financial results, revealing lower-than-expected sales in its electrophysiology division, which diminished market confidence in the company's future performance.
- Stock Price Plunge: Following the earnings report, Boston Scientific's stock price fell by $16.12, or 17.6%, closing at $75.50 per share on February 4, 2026, reflecting investor disappointment in the company's performance.
- Legal Context: Pomerantz LLP, a prominent securities class action law firm with over 85 years of experience, focuses on advocating for victims of securities fraud and corporate misconduct, underscoring its expertise and influence in such cases.
See More
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- Meeting Results: At today's special meeting, 91.99% of disinterested shareholders approved the proposal to issue up to 56,565,697 common shares to La Mancha, demonstrating strong confidence in the company's future.
- Voting Participation: A total of 260,820,988 shares were voted, representing approximately 55.4% of the company's issued common shares, indicating high shareholder engagement and interest in corporate matters.
- Management Outlook: CEO Clovis Torres expressed that shareholder support will facilitate the successful advancement of the Volta Grande Gold Project, with expectations to close the private placement in the coming days.
- Company Background: Belo Sun Mining Corp. focuses on mineral exploration and development in Brazil, particularly its 100% owned Volta Grande Gold Project, aiming to leverage this private placement to further advance the project.
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ORBIMED Reduces Stake in Terns Pharmaceuticals
- Share Reduction Transaction: According to a SEC filing dated February 17, 2026, ORBIMED Advisors LLC sold 5,409,671 shares of Terns Pharmaceuticals for approximately $125 million, indicating a potential decrease in confidence regarding the company's future prospects.
- Holding Changes: Following this sale, ORBIMED retains 2,153,300 shares of Terns, with a value decrease of $30.20 million, reflecting fluctuations in market expectations for its clinical pipeline.
- Market Performance: As of February 17, 2026, Terns' stock price stood at $39.58, marking an 858.4% increase over the past year, significantly outperforming the S&P 500 by 862.96 percentage points, showcasing strong market confidence in its biotech potential.
- Investor Focus: With upcoming clinical data releases, investors should monitor Terns' cash flow and trial results to assess whether its pipeline justifies the current high valuation, especially since robust data is crucial for sustaining valuation in the biotech sector.
See More
ORBIMED Reduces Stake in Terns Pharmaceuticals
- Stake Reduction Size: ORBIMED Advisors LLC disclosed in an SEC filing on February 17, 2026, that it reduced its stake in Terns Pharmaceuticals by 5,409,671 shares, with an estimated transaction size of $125.01 million, reflecting a cautious outlook on the company's future prospects.
- Position Value Change: Following this transaction, ORBIMED's position in Terns decreased to 2,153,300 shares, with a value drop of $30.20 million, indicating the market's sensitivity to fluctuations in the company's stock price.
- Asset Management Proportion: After the reduction, Terns now represents 1.78% of ORBIMED's reportable AUM, falling outside the top five holdings, which suggests a diminished significance in the investment portfolio.
- Market Performance Comparison: As of February 17, 2026, Terns' stock price stood at $39.58, reflecting an 858.4% increase over the past year, significantly outperforming the S&P 500 by 862.96 percentage points, demonstrating strong market confidence in its clinical pipeline.
See More
