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Early Alert: Stent and Electrocautery-Enhanced Delivery System Issue from Boston Scientific
The FDA is aware that Boston Scientific has issued a letter to affected customers recommending certain stents and electrocautery enhanced delivery systems be removed from where they are used or sold.
Certain AXIOS Stent and Electrocautery Enhanced Delivery Systems have increased reports of issues with stent deployment and expansion. This issue occurs at the time of delivery of the stent and does not affect successfully implanted stents. Difficulty deploying the stent may prolong the procedure so the device may be exchanged for a new one.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at ComplaintCallCenter@bsci.com.
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