Thousands of Boston Scientific catheters have been recalled because of problems with the catheter tip, which may detach during use, posing an increased risk of serious injuries and emergency surgery to remove the catheter.
The FDA announced the Boston Scientific catheter recall on Tuesday, due to an unreasonable risk of tip detachments, which may cause an obstruction in a patient’s blood vessels.
The recall involves Boston Scientific Corporation IMAGER II 5F Angiographic Catheters, which are used to provide a pathway to deliver contrast agents to blood vessels, including carotid arteries.
According to the FDA, the tips of the catheters have the potential to become detached during a patient procedure or during procedure preparation, especially during extraction, which would require additional surgical intervention to remove the catheter tip in the patient’s blood vessel, increasing time in the hospital.
The FDA warns healthcare providers and surgeons that, in the event of the catheter tip becoming detached during a procedure, patients could experience serious and life-threatening health consequences, including obstruction of blood flow, stroke, or death.
The recall involves approximately 6,130 IMAGER II 5F Angiographic Catheters manufactured by Boston Scientific Corporation of Marlborough, Massachusetts. They were distributed to healthcare and surgical centers across the nation from July 16, 2018 to November 26, 2019.
The FDA advises healthcare professionals to stop using the impacted products immediately and to remove them from all hospital inventory.
On February 11, Boston Scientific issued a letter to customers informing them on the potential issue and gave instructions on how to complete the Verification Form to include that quantity and lot numbers in the facility’s possession.
On April 7, the FDA categorized the letter as a Class I recall, the most serious classification, indicating the agency believes the use of the product poses a risk of serious adverse health consequences and even death.
Customers with additional questions or concerns regarding the recall are encouraged to contact their local Boston Scientific sales representative at BSCFieldActionCenter@bsci.com. Customers who have experienced adverse reactions or quality problems with the devices are being asked to report them to the FDA ‘s MedWatch adverse event reporting program.