Cook Medical expanded its Class I recall for beacon tip angiographic catheters to include additional lots, according to an FDA press release.
Bloomington, Ind.-based Cook Medical’s Beacon Tip Angiographic Catheters are used to inject contrast die into blood vessels in the heart to prepare for cardiac angiograms used to diagnose heart conditions.
The recall was initially filed in July over issues with tip splitting or separation of the device which can lead to the loss of function and separation that may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.
