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Boston Scientific halts sales of angiographic catheters amid 2 serious injuries
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Fusion42 · 2 September 2026 · Fusion42 review
Boston Scientific has halted sales of its Imager II angiographic catheters following reports of tip degradation causing two serious injuries. The FDA issued an early alert warning of a life-threatening risk of embolism from device fragments obstructing blood flow.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
Regulators have raised the barrier for device makers with safety lapses linked to serious injury. You must reassess your product risk controls immediately to avoid market disruption or recalls.
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1 source · 2 Sep 2026
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