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Cook Medical Beacon Tip Angiographic Catheters Recall

On July 2, 2015, Cook Medical voluntarily recalled 2,239 specific lots of the Beacon Tip Angiographic Catheters. Worldwide, 95,167 devices are affected by this recall. In the United States, 38,895 devices have been recalled.

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The specific versions and lot numbers of angiographic catheters that Cook Medical recalled are the Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters. 1

Catheter Malfunction and Injuries

According to the U.S. Food and Drug Administration (FDA), Cook Medical has received complaints that its Beacon Tip Angiographic Catheters tips may split or break off from the catheters. If a tip enters the patient’s bloodstream, serious injury could occur, additional medical intervention may be required to retrieve the tip, and death could result. 2

Catheters May Break During Use

According to the FDA, the Cook Medical angiographic catheters have been recalled because Cook Medical has received complaints that “the catheter tip may split or separate,” which may result in malfunctioning or adverse events 3

So far, Cook Medical has received more than two dozen complaints of catheter tip splitting, separation or both. In addition, 14 Medical Device Reports have been recorded documenting tip splitting or separation. 4

Tip Splitting May Cause Device Malfunction

According to Cook Medical, “Tip splitting has the potential to lead to loss of device function. Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.” 5

The Beacon Tip Angiographic Catheters specified in this recall were distributed for two years, from June 6, 2013, through June 25, 2015. 6

Cook Medical Customers Instructed to Discontinue Using Beacon Tip Angiographic Catheters

In early July 2015, Cook Medical sent recall notification letters to its customers and distributors requesting “that all customers and distributors quarantine and discontinue use of all potentially affected units and return the affected product to the company as soon as possible for credit.” 7

Cook Medical has also notified other regulatory agencies of the recall. 8

FDA Classifies Recall of Cook Medical Catheters as Class 1

The FDA has classified this voluntary recall as a Class 1 recall.

A Class 1 recall indicates that the device may “cause serious adverse health consequences or death.” This is the most severe type of recall. 9

The Cook Medical Beacon Tip angiographic catheters are used to “inject dye into blood vessels in the heart to prepare it for a type of X-ray used to diagnose heart conditions (cardiac angiogram).” 10

The FDA points out that, “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.” 11

According to the FDA, these particular Cook Medical angiographic catheters may split or separate during angiographic procedures, possibly causing serious injury. 12

  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/MedicalDevices/Safety/ListofRecalls/ucm457629.htm 

  4. http://www.fda.gov/Safety/Recalls/ucm457068.htm 

  5. http://www.fda.gov/Safety/Recalls/ucm457068.htm 

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

  7. http://www.fda.gov/Safety/Recalls/ucm457068.htm 

  8. http://www.fda.gov/Safety/Recalls/ucm457068.htm 

  9. http://www.fda.gov/Safety/Recalls/ucm165546.htm 

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

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

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