Cook Medical announced that it has expanded its voluntary recall of angiographic catheters to include all lots of specific sizes.
The catheters have exhibited tip splitting or separation, resulting in the FDA receiving a total of 42 Medical Device Reports.
“Tip splitting has the potential to lead to loss of device function,” the official release read. “Tip separation may require medical intervention to retrieve a separated segment or, if not retrieved, has the potential to occlude blood flow to end organs.”
The recall covers different versions of the Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, Slip-Cath Beacon Tip Hydrophilic Catheters, and Shuttle Select Slip-Cath catheters.
The specific products in question were distributed from September 2012 to September 2015 and can be identified by the part number located on the outer package product label. Full lot information, as well as contact information for Cook Medical and information on how to report adverse events related to the catheters, can be found on the FDA’s website.
The original lot-specific recall was initiated in July.