October 12, 2015 — After receiving 42 adverse event reports, Cook Medical has expanded a recall for angiographic catheters that can cause deadly complications when the tip splits or breaks off inside a patient’s body.
A smaller recall was issued for the Beacon-Tip catheters on July 2. Only 26 complaints had been reported at that time.
The expanded recall includes more types of catheters that were distributed globally from September 2012 through September 2015. The recall includes all lots currently in distribution.
According to the FDA, broken catheter tips can travel in a patient’s bloodstream and cause severe, life-threatening complications:
“Tip splitting has the potential to lead to loss of device function. 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.”
Recalled Beacon Tip Angiographic Catheters:
- Beacon Tip Torcon NB Advantage Catheters
- Beacon Tip Royal Flush Plus High-Flow Catheters
- Shuttle Select Slip-Cath Catheter
- Slip-Cath Beacon Tip Catheters
An angiographic catheter is a thin plastic tube that is used to inject contrast dye into blood vessels so they appear on X-rays. Broken catheters are extremely serious and may be difficult or impossible to retrieve.
On October 5, a man from Louisiana filed a lawsuit after a broken catheter made by Covidien and Medtronic broke inside his brain. He was undergoing a procedure to remove blood clots and improve circulation. Instead, the broken catheter got stuck in an artery in his brain, where it remains today. The lawsuit was filed in federal court in Louisiana (Case No. 2:15-cv-04835).
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