Boston Scientific Shares Rise 0.17% as FDA Warns of LAAC Device Risks, Trading Volume Ranks 177th

On August 8, 2025, Boston Scientific (BSX) rose 0.17% with a trading volume of $0.53 billion, ranking 177th in market activity. The FDA issued a safety communication regarding updated use instructions for specific Watchman left atrial appendage closure (LAAC) access systems, citing 120 serious injuries and 17 deaths linked to air embolism risks during procedures lacking positive pressure-controlled ventilation. The agency emphasized heightened risks for patients with pre-existing low left atrial pressure or hypovolemia, prompting Boston Scientific to revise procedural guidelines, including device exchange protocols and valve positioning adjustments. The company plans to integrate these updates into physician training programs.

Regulatory scrutiny over device safety remains a key factor for the stock, with the FDA’s pilot program aimed at strengthening medical device recall processes. Boston Scientific’s proactive measures, such as detailed procedural revisions and training enhancements, aim to mitigate risks but underscore ongoing challenges in managing product safety profiles. The company’s focus on reducing air embolism incidents aligns with its broader strategy to address complications in LAAC procedures, though investor sentiment may remain cautious amid reported adverse events.

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