The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding Boston Scientific's Imager II Angiographic Catheters, following the company's recommendation for customers to remove all affected devices due to a manufacturing defect. Boston Scientific has also decided to discontinue selling this product.
The recall stems from a manufacturing issue where catheters were produced with reduced levels of stabilizing agents in their tips, increasing the risk of tip degradation and detachment. While no increase in tip detachment complaints has been identified for affected lots, the devices were manufactured outside approved design specifications.
Potential adverse health consequences range from a delay in procedure to, in remote cases, life-threatening embolism resulting from a device fragment obstructing blood flow and causing end organ failure. As of July 16, Boston Scientific has reported two serious injuries associated with this issue, with no deaths.
The FDA's Center for Devices and Radiological Health (CDRH) said, "CDRH is issuing this 'Early Alert' to notify the public of a potentially high-risk device issue." The agency will continue to update the public as new information becomes available. Customers with questions should contact Boston Scientific at BSCComplaints@bsci.com.