October 12, 2015 — Cook Medical is expanding a recall for thousands of angiographic catheters after receiving 42 reports that the tip broke off or split.
A broken Beacon-Tip catheter could enter the patient’s bloodstream, resulting in serious injury or death. According to the FDA:
“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.”
The expanded recall involves catheters that were distributed globally between September 2012 and September 2015. All lots currently in distribution are affected.
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
Angiographic catheters are thin plastic tubes that are inserted into an artery through a small incision in the skin. After the catheter is guided into the heart, a contrast material is injected through the tube. Images of blood vessels are taken with X-rays.
On October 5, a lawsuit was filed in Louisiana by a man who was injured when a catheter made by Covidien and Medtronic broke. According to the complaint, Herman Helmer Jr. underwent a procedure to remove a blood clot and improve circulation to his brain. When the catheter was removed, the tip broke off and traveled to an artery in his brain, where it remains.
The device-makers are accused of negligence for selling a defective product. The lawsuit was filed in the U.S. District Court for the Eastern District of Louisiana (Case No. 2:15-cv-04835).
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