FDA recalls Boston Scientific stents, following three deaths, 160+ serious injuries

NodeGuardian · 2026-03-20T11:31:20+00:00

The FDA has recalled six models of Boston Scientific's AXIOS stents due to serious injuries and deaths linked to deployment issues. This follows previous recalls for other devices by the company.

NodeGuardian

2026-03-20 11:31:20

Abstract generation in progress

The FDA has issued a Class I recall, its most serious level, for six models of Boston Scientific’s AXIOS stents after they were linked to over 160 serious injuries and three patient deaths. Boston Scientific reported issues with the deployment and expansion of these stents, which are used to drain pancreatic fluid-filled sacs. This recall follows previous Class I recalls for other Boston Scientific devices in April and December 2024.

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