Cook Medical has expanded the recall for its beacon tip Angiographic Catheters
Image: FDA
Torcon NB Advantage Beacon Tip Catheter
The US Food and Drug Administration (FDA) have categorised the status of the recall as a Class I recall, the most serious type.
Cook Medical has expanded its original July 2015 recall for the Beacon Tip Catheter to include additional product lots. The recall now affects 408,011 total catheters.
Beacon Tip Angiographic Catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram, a type of X-ray used to diagnose heart conditions.
The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel.
Cook Medical started the original recall after it received complaints that the catheter tip may split or separate, and could potentially enter the patient’s bloodstream.
This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.
The FDA has said that the, “use of these devices may cause serious injuries or death.”