Boston Scientific Pulls Imager II Catheters After Recall

Boston Scientific has decided to discontinue its Imager II Angiographic Catheters after a manufacturing problem that increased the risk of the catheter tip detaching led the company to pull the devices from the market. Reported by MedTech Dive on 31 August 2026 following an early alert posted by the FDA on 29 August, the company has instructed customers to immediately stop using or distributing all Imager II Angiographic Catheters.

The Imager II is a single-use catheter used to create images of areas of interest in the peripheral vasculature, available in a variety of shapes and lengths. Boston Scientific determined affected devices were manufactured with reduced levels of stabilising agents in the tip, introducing the risk of the tip degrading or detaching. The most common adverse event associated with tip detachment is a procedure delay to exchange for a new device, though the FDA notice highlighted potential life-threatening blockage from a device fragment obstructing blood flow. Boston Scientific reported two serious injuries associated with the problem as of 16 July 2026.

Boston Scientific said no increase in tip detachment complaints was identified, but the company is still removing the devices as they were manufactured outside design specification, and had decided earlier this year to discontinue the Imager II catheter. The removal follows Boston Scientific’s July 2026 recall of another catheter used in a Silk Road Medical stroke prevention system (acquired by Boston Scientific in 2024). The company is also managing a recent cyberattack that disrupted product manufacturing and an ongoing restructuring programme involving up to $800 million in charges.

The commercial signal is a Boston Scientific franchise navigating multiple simultaneous operational challenges (recall, cyberattack, restructuring) that create meaningful competitive openings across peripheral vasculature and neurovascular catheter markets. Expect Medtronic, Abbott, Terumo, Cordis (Cardinal Health) and AngioDynamics to sharpen their positioning across angiographic and peripheral catheter categories through the rest of 2026 and into 2027 as Boston Scientific manages remediation.

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