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Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Glytec wins Breakthrough designation for insulin dosing software in newborns Perfuze bench study puts Millipede88 first-pass success at 88 percent in MCA models Precision Neuroscience raises $250M Series D and takes total funding to $430M FDA calls BD's kit correction Class I over recalled saline ampules from a supplier FDA early alert flags a loose cable that reboots React Health VOCSN ventilators Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Glytec wins Breakthrough designation for insulin dosing software in newborns Perfuze bench study puts Millipede88 first-pass success at 88 percent in MCA models Precision Neuroscience raises $250M Series D and takes total funding to $430M FDA calls BD's kit correction Class I over recalled saline ampules from a supplier FDA early alert flags a loose cable that reboots React Health VOCSN ventilators

Class I recall

FDA makes the Boston Scientific Imager II removal a Class I recall

MedDevice Startups Staff · 2 days ago · 2 min read · Via FDA recall notice

FDA classified Boston Scientific's removal of Imager II angiographic catheters as Class I on September 25. Two serious injuries had been reported as of July 16. There were no deaths.

The cause is a manufacturing defect that left less stabilizing agent in the catheter tips. Tips can degrade and detach. FDA says a fragment can block blood flow and cause a life-threatening embolism, though complaints never increased.

Boston Scientific told customers to stop use, segregate inventory, check UPN numbers on inner and outer packaging, and return product with a verification form. Patients already treated stay under monitoring. The company said in early September that it was ending the line rather than correcting it.

Two injuries and a flat complaint trend still produced the agency's most serious recall class. The argument FDA is making is deviation from the cleared specification, which is a reminder that your own conformance data can set the class before any signal shows up in the field.

Questions & Answers

Why did FDA classify the Boston Scientific Imager II recall as Class I?

FDA set the Imager II angiographic catheter recall at Class I on September 25, 2026 because a manufacturing defect can let catheter tips degrade and detach. A detached fragment can obstruct blood flow and cause a life-threatening embolism.

How many injuries are linked to the Boston Scientific Imager II catheters?

Boston Scientific reported two serious injuries as of July 16, 2026, and no deaths, in connection with the Imager II angiographic catheter recall.

Is Boston Scientific still selling Imager II angiographic catheters?

No. Boston Scientific said in early September 2026 that it was ending the Imager II line, and the September 25 Class I recall tells customers to segregate and return affected inventory.

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