Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature.
Boston Scientific determined the catheters were “manufactured with reduced levels of stabilizing agents in the tips,” according to the early alert. The issue could “increase the risk of tip degradation and detachment,” the company said.
The company has reported two serious injuries associated with the issue as of July 16, and is removing affected products from the market.
Boston Scientific made the decision earlier this year to discontinue commercialization of the Imager II catheter, the company said in a statement to MassDevice.
“The product will no longer be available for intravascular procedures following this removal,” a company spokesperson said. “There is no action needed from patients who previously had a procedure performed with the device.”
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The most common possible adverse event related to tip detachment is a delay in the procedure to exchange for a new device, the early alert said. The most serious potential adverse event associated with the issue is life-threatening embolism resulting in organ failure, caused by a device fragment obstructing blood flow.
In an Aug. 24 letter, the device developer advised affected customers to immediately stop further use and distribution of the catheters.
The company recommended healthcare facilities that often remove products from the outer packaging for storage verify both the inner and outer packaging UPN codes when identifying affected products, since the codes are unique, and return the products.
Boston Scientific issued a similar recall in July 2026 following reports of arterial sheath tip separation or partial tip separation during use of certain percutaneous catheter systems.
