FDA Class I Recall for Boston Scientific’s IMAGER II Angiographic Catheters
Nine injuries have been reported due to catheter tips detaching during procedures or prep.
Boston Scientific is recalling its IMAGER II 5-F5 angiographic catheters because there is a potential for the catheter tip to become detached either during the procedure or while preparing for it. The US Food and Drug Administration has deemed this a Class I recall, the most serious type.
The IMAGER II 5-Fr catheters are used as a pathway for delivering contrast agents during angiographic procedures. According to the FDA, there have been nine reported cases of injury.
In February 2020, Boston Scientific sent a letter to customers advising them of all affected lot numbers, that they be removed from hospital inventory, and no longer used. The 6,130 devices involved in the recall were distributed between July 2018 and November 2019, with expiration dates that range from June 2020 through March 2021.
Customers with questions are asked to contact their local sales representative or BSCFieldActionCenter@bsci.com.