Boston Scientific halts sales of angiographic catheters amid ‘two serious injuries’

MedTech Boston Scientific halts sales of angiographic catheters amid ‘two serious injuries’ By Ben Adams Sep 1, 2026 8:42am Boston Scientific catheters FDA Diagnostics Boston Scientific has told its customers to stop using its Imager II angiographic catheters upon learning that a manufacturing issue has impacted the tips of the devices. In an FDA early alert, the U.S. regulator said it had been made aware that Boston Scientific sent out a letter on August 24 recommending that “all Imager II Angiographic Catheters be removed from where they are used or sold.” The devices are used by specialists to capture images of the body’s blood vessels.

In its letter, the medtech said it had found that the catheters were made with “reduced levels of stabilizing agents in the tips,” something that could “increase the risk of tip degradation and detachment.” The FDA said the most serious concern with this issue is a “life threatening embolism resulting from a device fragment obstructing blood flow resulting in end organ failure.” Boston Scientific had reported two serious injuries and no deaths associated with this issue as of July 16. There have been so subsequent updates. Related FDA elevates cardiovascular catheter recalls from Boston Scientific, Route 92 Medical Two years ago, Boston Scientific was the subject of a Class I recall from the FDA following reports of the catheter tip breaking off one of its devices while inside the patient.

The recall compounds an already challenging year for Boston Scientific. This alert comes less than a week after the company was hit by a serious cyberattack that has impacted its global operations and aspects of its manufacturing base. The company also earlier this year announced a restructuring plan, which could lead to “some headcount reductions,” and lowered its top guidance estimates by 2% amid sales headwinds.

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