Boston Scientific is recalling their Imager II 5F angiographic catheters in the United States because the catheter tip could become detached during a patient procedure or during procedure preparation.
The US Food and Drug Administration (FDA) has identified this as a Class 1 recall, the most serious kind, because of the potential for serious injury or death. To date, there have been nine reported injuries related to this recall.
"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. There is also the potential for serious adverse events including obstruction of blood flow (embolism), stroke, or death," according to the FDA recall notice.
Specific details of the recalled devices are available in the notice. The recall covers 6130 single units (1226 five-packs) distributed in the United States from July 16, 2018 to November 26, 2019.
Boston Scientific has sent an urgent medical device removal letter to customers, listing the affected lot numbers and asking customers to stop using the catheters and remove them from inventory and return the affected lots to the company.
Customers with questions about the recall are asked to contact their local sales representative or BSCFieldActionCenter@bsci.com.
Adverse reactions or quality problems related to this recall should be reported to the FDA's MedWatch program.
Cite this: FDA Class 1 Recall of Imager II Angiographic Catheters - Medscape - Apr 07, 2020.