Boston Scientific intends to stop selling and recall Imager II Angiographic Catheters from the market after the company disclosed a manufacturing problem that could increase the risk of the catheter tip detaching during use. The company sent customers a letter last week asking them to immediately stop using or distributing all affected devices, while the U.S. Food and Drug Administration (FDA) issued an early alert about the problem on Friday.
Boston Scientific said that two serious injuries were linked to the problem as of July 16. Single-use Imager II catheters are used to image areas of the peripheral blood vessels and are available in multiple configurations and lengths. The risk occurs because the catheters were manufactured with low levels of bonding materials at the tip, which could lead to its deterioration or detachment.
Risks of Tip Detachment
The most common effect of tip detachment may be limited to a delay in the procedure because the catheter must be replaced with another device. However, the FDA notice warns of more serious complications, as a detached part of the device could obstruct blood flow inside the vessel, potentially causing a life-threatening blockage.
The company explained that it had not observed an increase in complaints of tip detachment among the affected lots, but decided to remove the devices from the market because they were manufactured outside the design specifications. Boston Scientific did not provide additional details about the reason for its decision to discontinue the product, but said the decision to dispose of the Imager II catheter was made earlier in the year and that the device would no longer be available for medical procedures after the recall.
What Should Healthcare Facilities Check?
Boston Scientific asked healthcare facilities to review their inventories using universal product numbers (UPNs) to determine whether they contain affected devices. Facilities need to note that a catheter removed from its packaging bears a different code from the one on the outer package, a point that could affect the accuracy of an inventory search.
- Stop using or distributing all Imager II catheters covered by the notice.
- Check the UPNs on the device and the outer package, taking into account the difference between the two codes.
- Quarantine products confirmed to be affected according to the company’s instructions and the safety notice.
Why Does This News Matter?
The development is not limited to a commercial announcement discontinuing a product; it is directly related to the safety of a device used during blood-vessel imaging procedures. The recall decision means that facilities relying on these catheters will need to review their inventories and avoid using affected devices, while the scope of the affected lots and details of the discontinuation decision still require reference to the company’s notice and FDA statements. The action also follows the removal of another catheter from the market earlier in the summer because of a tip-detachment risk; that catheter was part of a stroke-prevention system belonging to Silk Road Medical, which Boston Scientific acquired in 2024.