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FDA Issues Recall of Cook Medical Angiographic Catheters

Terri Ackerman

Last updated: October 26, 2016 3:18 pm

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On July 2, the U.S. Food and Drug Administration (FDA) classified the Class I recall of specific catheters called the Beacon Tip Angiographic Catheters, manufactured by Cook Medical. 1

According to the FDA, “Cook Medical has received complaints that the catheter tip may split or separate from the catheter. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.” 2

The recall included in total 38,895 Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters distributed from June 6, 2013 to June 25, 2015.

Cook Medical has issued a voluntary recall of these catheters. At the time of the FDA’s classification, the company had “received 26 reports of the device malfunctioning, with 14 resulting in reports of adverse events.” 3

According to the FDA, Cook Medical Beacon Tip Angiographic Catheters “are used to inject contrast dye into blood vessels in the heart to prepare it for a type of X-ray used to diagnose heart conditions (cardiac angiogram). The catheter is inserted into the body through a small puncture made in the skin and placed into the blood vessel along a guide wire before injecting the contrast dye.” 4

Dye makes the blood vessels in the heart visible on an X-ray. Patients are sedated but awake during the procedure, which may last 30 to 60 minutes. 5

Coronary Angiogram Procedures Involve Heart Catheterization

An angiographic procedure is a specific type of X-ray examination that takes pictures of blood flow in an artery or vein. 6 A special dye is inserted through a catheter into a blood vessel so that blood flow can be monitored. 7

Angiographic procedures allow doctors to examine the arteries or veins in various parts of the body, including the head, chest, or belly. 8 Angiogram procedures are named for the areas they are examining. For example, a cerebral angiogram looks at the blood vessels in the brain and a coronary angiogram examines heart blood flow. 9

Coronary, or heart, angiogram procedures “are part of a general group of procedures known as heart (cardiac) catheterization.” 10 Heart catheterization procedures can help doctors “diagnose and treat heart and blood vessel conditions.” 11

What Happens During Heart Angiography Procedures

In preparation for a heart angiogram examination, the doctor inserts a catheter into a blood vessel in your arm, neck or groin. A catheter is a “long, thin, flexible tube.” 12 This tube can then move through the blood vessel into the heart. 13

Once the catheter is inserted, the doctor can perform a variety of diagnostic tests and treat some heart conditions. During heart angiography procedures, the doctor inserts dye so that arteries will show up on X-ray pictures. 14

When dye is visible in the coronary arteries, doctors can see if plaque has accumulated. This waxy substance can narrow, or even block, blood flow to the heart. Plaque buildup in the coronary arteries is called coronary heart disease or coronary artery disease. 15

During cardiac catheterization, doctors can also use ultrasound to see blockages in the heart’s arteries. In this procedure, sound waves reveal pictures of the heart’s blood vessels. 16

Cardiac catheterization can also allow doctors to take blood or heart muscle samples. 17

There are other procedures that your doctor may perform during heart catheterization. These include:

  • Measuring heart blood flow and pressure
  • Determining oxygen levels in the heart
  • Performing a biopsy
  • Checking the heart’s ability to pump blood
  • Examining the heart’s valves 18
  1. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm 

  2. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm 

  3. http://www.fda.gov/Safety/Recalls/ucm457068.htm; http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm 

  4. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm 

  5. http://www.nhlbi.nih.gov/health/health-topics/topics/cath; https://medlineplus.gov/ency/article/003419.htm 

  6. http://www.webmd.com/heart-disease/angiogram 

  7. http://www.webmd.com/heart-disease/angiogram 

  8. http://www.webmd.com/heart-disease/angiogram  

  9. http://www.webmd.com/heart-disease/angiogram; http://my.clevelandclinic.org/services/heart/diagnostics-testing/invasive-testing/cardiac-catheterization 

  10. http://www.mayoclinic.org/tests-procedures/coronary-angiogram/basics/definition/prc-20014391 

  11. http://www.mayoclinic.org/tests-procedures/coronary-angiogram/basics/definition/prc-20014391 

  12. http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  13. http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  14. http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  15. http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  16. http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  17. http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  18. https://medlineplus.gov/ency/article/003419.htm; http://www.mayoclinic.org/tests-procedures/cardiac-catheterization/basics/why-its-done/prc-20023050