|
The instructions for the TRUFILL n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System contain an incorrect statement in the Instructions for Use. The use of the incorrectly mixed product can result in the liquid mixture solidifying too slowly in the intended areas, and unintended embolization or reflux into arteries and pulmonary vessels. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm383656.htm
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |
 |
|
