April 7, 2020 — Boston Scientific Corp. is recalling its Imager II 5 French angiographic catheters, because there is a potential for the catheter tip to become detached during a procedure or during procedure preparation.
The U.S. Food and Drug Administration has listed this as a Class I recall. The FDA said there have been nine reported patient injuries due the the problem with the catheters. The FDA said 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 FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The lots affected include those distribution between July 16, 2018 to Nov. 26, 2019. The number of devices being recalled in the U.S. is 6,130.
On Feb. 11, 2020, Boston Scientific sent a letter to customers informing them of the affected lot numbers and provided the following instructions:
• Remove any affected lots in the hospital inventory
• Stop using any product with the affected lot number
• Complete the Verification Form and include the quantity of units from each affected lot
• Return the affected lots to Boston Scientific Corporation