
Angiographic Catheters Recall: Cook Inc. Removes Beacon Tip Angiographic Catheters Due to Tip Separation
Cook Inc. is recalling the Cook Beacon Tip 5.0 Fr Angiographic Catheter due to reports that certain device lots may experience tip separation. Identified through field complaints, users reported tip separation occurring both prior to and during patient contact.
If an affected product is used, potential patient harms such as catheter fragmentation and embolization may occur. Medical consequences associated with device fragmentation or separation may include sepsis, vessel perforation, thrombosis, embolism, cardiac arrythmia, and death.
At this time, Cook Inc. has reported three serious injuries and no deaths related to this issue.
This recall involves removing certain devices from where they are used or sold. The U.S. Food and Drug Administration (FDA) has identified this recall as a Class I recall, the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Cook Medical at FieldActionsNA@CookMedical.com or 1-800-457-9120.
|