At least nine people have been injured by a faulty cateter tip on Boston Scientific's Imager II 5F Angiographic Catheters, FDA reported this week. The company initiated a recall of the device in February that includes 6,130 of the catheters distributed between July 16, 2018 and Nov. 26, 2019. Click here for a full list of affected lot numbers.
The catheters are used to provide a pathway to deliver contrast agents to blood vessels. FDA said there is a potential for the catheter tip to become detached during a patient procedure or during procedure preparation. According to the recall notice from FDA, use of the affected product may lead to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital. The agency said there is also the potential for serious adverse events including obstruction of blood flow (embolism), stroke, or death.
Customers have been asked to remove any affected lots in the hospital inventory, stop using product with the affected lot number, and return to the company. Customers who have questions about the notification should contact their local sales representative or BSCFieldActionCenter@bsci.com.