Boston Scientific: Imager II angiographic catheters
Boston Scientific recalled its Imager II 5F angiographic catheters in February 2020. The FDA labeled the recall as Class I on April 7.
The recall involved 6,130 devices, which are used to provide a pathway to deliver contrast agents to blood vessels, including carotid arteries. The devices in the recall had the potential for the catheter tip to become detached during a patient procedure or during procedure preparation. Using the device could have led to additional surgical intervention to remove the catheter tip in the patient’s blood vessel and increased time in the hospital. The device also had the potential for serious adverse events, including obstruction of blood flow, stroke or death.
There were nine reported injuries related to the device recall, according to an April 7 FDA letter.
Boston Scientific told healthcare providers to remove any affected lots from the hospital inventory and stop using the products with the affected lot number.
“There is no risk to patients who have had a previous procedure performed with this device. All products within the advisory have been retrieved from the U.S. market,” a Boston Scientific spokesperson told MT+E.
Catheters involved in the recall were distributed between July 16, 2018, and Nov. 26, 2019.