FDA Classifies Recall of Boston Scientific Imager II Angiographic Catheters as Class I

The U.S. Food and Drug Administration (FDA) has classified the recall of Boston Scientific Imager II Angiographic Catheters as a Class I recall, the most serious category used by the agency. The affected catheters are being removed from locations where they are stored, sold or used.

The Imager II is a sterile, single-use catheter used during procedures to obtain images of selected areas of the peripheral blood vessels. The devices are manufactured in different shapes and lengths for use in vascular procedures.

The recall follows the identification of a manufacturing issue involving the tip of the catheter. Boston Scientific determined that affected devices were manufactured with reduced levels of stabilising agents in the catheter tip. This condition can increase the possibility of degradation or detachment of the tip during use.

If a catheter tip becomes detached within a blood vessel, the immediate consequence may be a delay in the procedure while the device is exchanged. In more serious circumstances, a detached fragment could obstruct blood flow and potentially cause a life-threatening embolism.

The FDA reported that Boston Scientific had received reports involving two serious injuries associated with the issue as of 16 July 2026, with no deaths reported in connection with the problem at that time.

The company had previously instructed affected customers to immediately stop using or distributing the relevant devices, segregate them from other inventory and return them. Healthcare facilities have also been advised to check product identification numbers carefully because the codes on inner and outer packaging may differ.

The FDA stated that the affected products were manufactured outside their approved design specifications. Boston Scientific has also decided to discontinue sales of the Imager II Angiographic Catheters.

The recall highlights the importance of maintaining manufacturing specifications and monitoring device quality throughout the product lifecycle.

25-09-2026