Dive Brief:
- Boston Scientific plans to stop selling certain angiographic catheters after a manufacturing problem led the company to pull the devices from the market.
- The medical device manufacturer sent a letter to customers last week instructing them to immediately stop using or distributing all Imager II Angiographic Catheters due to an issue that can increase the risk of the tip detaching. The Food and Drug Administration posted an early alert on Friday.
- Boston Scientific had reported two serious injuries associated with the problem as of July 16.
Dive Insight:
Boston Scientific’s Imager II catheters are used to create images of areas of interest in the peripheral vasculature. They are single-use devices, and come in a variety of shapes and lengths.
The medtech firm determined that the catheters were manufactured with reduced levels of stabilizing agents in the tip, which could introduce the risk of the tip degrading or detaching. The most common adverse event associated with tip detachment is a procedure delay to exchange for a new device. However, the problem could lead to serious complications, such as a life-threatening blockage from a device fragment obstructing blood flow in a vessel, according to the FDA notice.
Boston Scientific said that no increase in tip detachment complaints has been identified with the affected lots, but it is still removing the devices from the market as they were manufactured outside of design specification. The company did not share more details about why it was discontinuing the product.
Boston Scientific decided earlier this year to discontinue the Imager II catheter, a company spokesperson wrote in an email. The device will no longer be available for procedures following the product removal.
The company said healthcare facilities should verify using universal product numbers whether any of their inventory was affected. Devices taken out of the carton will have a different code than the outer packaging, which is important to note when searching for affected products.
Earlier this summer, Boston Scientific removed another catheter from the market over the risk of tip separation. That product was used as part of a stroke prevention system made by Silk Road Medical, which Boston Scientific acquired in 2024.
Editor’s note: This article has been updated with comments from Boston Scientific.
