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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

Recall

Boston Scientific pulls Imager II catheters over degrading tips and ends the product line

MedDevice Startups Staff · 6 days ago · 2 min read · Via MassDevice

Boston Scientific told customers on August 24 to remove every Imager II angiographic catheter from use and from sale. The tips contain reduced levels of stabilizing agents, which can let them degrade and detach. Two serious injuries had been reported as of July 16, with no deaths.

The FDA flagged the risk of a device fragment blocking blood flow, up to a life threatening embolism and organ failure. Boston Scientific is not fixing the product. A spokesperson said the company will discontinue commercialization, so the catheter will no longer be available for intravascular procedures.

A material specification took out an entire catalog line. Incoming inspection on a polymer additive rarely gets the scrutiny a sterilization or software change does, and this is the failure mode it exists to catch.

Questions & Answers

Why is Boston Scientific recalling Imager II angiographic catheters?

Boston Scientific found reduced levels of stabilizing agents in the tips of Imager II angiographic catheters, which can let the tip degrade and detach. The company sent customers a removal letter on August 24, 2026.

Is Boston Scientific replacing the Imager II catheter?

No. Boston Scientific said it will discontinue commercialization of the Imager II angiographic catheter, and the product will not return for intravascular procedures.

How many injuries were reported with the Boston Scientific Imager II catheter?

Two serious injuries had been reported as of July 16, 2026, with no deaths, tied to the Boston Scientific Imager II angiographic catheter.

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