September 22, 2015 · FLEMING | NOLEN | JEZ, L.L.P.
Cook Medical is recalling nearly 40,000 angiographic catheters in the United States after reports that the catheter tip may break off or split. If this happens, the tip could enter the patient’s bloodstream, resulting in serious injury or death. Tip splitting or separation may also cause the device to stop working.
Cook Medical has received 26 reports of the device malfunctioning, with 14 resulting in reports of adverse events (the adverse events reported were not described).
The following angiographic catheters are being recalled:
- Beacon Tip Torcon NB Advantage Catheters.
- Beacon Tip Royal Flush Plus High-Flow Catheters.
- Slip-Cath Beacon Tip Catheters.
A total of 38,895 catheters are being recalled in the US. The catheters were manufactured from May 9, 2013, to September 1, 2014, and distributed from June 6, 2013, to June 25, 2015.