FDA News

FDA designates recall of angiographic catheters as class 1

The FDA has designated Boston Scientific’s recall of angiographic catheters used for contrast agent delivery as a class 1 recall, the most serious kind.

The recall affects 6,130 catheters (Imager II 5F) distributed in the United States between July 16, 2018 and Nov. 26, 2019, according to a safety alert from the agency.

The catheter, which is used to deliver contrast agents to blood vessels such as the carotid arteries, was originally recalled due to the tip potentially becoming detached during procedure preparation or the procedure itself. The detachment may lead to additional surgeries to remove the tip from the blood vessel in addition to increased time in the hospital, according to the agency.

Other serious adverse events may occur including stroke, embolism or death, according to the alert. Tip detachment has led to nine reported injuries.

Boston Scientific distributed a letter on Feb. 11, 2020 to customers alerting them of affected lot numbers and instructions on how to return the catheters, according to the alert.

The FDA has designated Boston Scientific’s recall of angiographic catheters used for contrast agent delivery as a class 1 recall, the most serious kind.

The recall affects 6,130 catheters (Imager II 5F) distributed in the United States between July 16, 2018 and Nov. 26, 2019, according to a safety alert from the agency.

The catheter, which is used to deliver contrast agents to blood vessels such as the carotid arteries, was originally recalled due to the tip potentially becoming detached during procedure preparation or the procedure itself. The detachment may lead to additional surgeries to remove the tip from the blood vessel in addition to increased time in the hospital, according to the agency.

Other serious adverse events may occur including stroke, embolism or death, according to the alert. Tip detachment has led to nine reported injuries.

Boston Scientific distributed a letter on Feb. 11, 2020 to customers alerting them of affected lot numbers and instructions on how to return the catheters, according to the alert.