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Boston Scientific halts sales of angiographic catheters amid 2 serious injuries

Published

2 September 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at fiercebiotech.com →

◆ Verified

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.

◆ Coverage

1 source · 2 Sep 2026

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◆ Topics

Medtechboston-scientificcathetersfda-alertmedical-safetyproduct-recall