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Beacon Tip Angiographic Catheter

In 2015, the manufacturer of Beacon Tip Angiographic Catheters voluntarily recalled specific lots of the device after reports about catheter tips splitting or separating. Cook Medical in 2016 expanded the recall to all catheters with the Beacon Tip technology. The Class 1 recall, the most serious kind, involved more than 4 million catheters.

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Problems with Cook Medical catheters surfaced shortly after they hit the market.

By 2016, the company had recalled more than 4 million Beacon Tip Angiographic Catheters after reports of tips splitting or separating.

This problem created the possibility of catheter tips entering patients’ blood vessels, causing serious injury or death and requiring medical intervention to retrieve the tip. Additionally, there was the probability of the device malfunctioning due to the splitting or separation.

Catheters are long thin, plastic tubes inserted into an artery through a small incision in the skin. Beacon Tip Angiographic Catheters were intended for use by physicians in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures.

What Is a Catheter Angiography?

Gloved Medical Professional Inserting Catheter in Patient
Catheters are inserted into an artery through a small incision in the skin.

A catheter angiography requires the use of a catheter, X-ray imaging and often an injection of contrast dye to examine blood vessels in the body for abnormalities, such as plaque and other blockages, aneurysms, spasms or narrowing. The procedure is usually minimally invasive as well as efficient by assisting in the simultaneous diagnosis and treatment of a patient, thereby limiting patient exposure and back-to-back procedures.

A catheter angiography can be used to examine blood vessels throughout various components of the body including the respiratory system, digestive system, kidneys and urinary system, cardiovascular system, brain, neck, pelvis, legs and feet, arms and hands. The area where the catheter is to be inserted is shaved, cleaned and often numbed with a local anesthetic unless sedation is required. Catheter angiographies can last anywhere from less than an hour to several hours depending on the patient and the nature of the procedure.

Intended Angiographic Catheter Uses

Beacon Tip Angiographic Catheters were intended for use in the peripheral and coronary vascular system, including the carotid arteries, by physicians and qualified health care professionals in angiographic procedures.

Product Models & Intended Uses
Beacon Tip Torcon NB Advantage Catheter
By physicians and qualified health care professionals in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures
Beacon Tip Royal Flush Plus High-Flow Catheter
By physicians and qualified health care professionals in angiographic procedures
BeaconTip Centimeter Sizing Catheter
By physicians and qualified health care professionals in angiographic procedures
Beacon Tip White Vessel Sizing Catheter
By physicians and qualified health care professionals in angiographic procedures
Beacon Tip Vessel Sizing Catheter
By physicians and qualified health care professionals in angiographic procedures
Shuttle Select Slip-Cath
By physicians and qualified health care professionals in angiographic procedures
Slip-Cath Beacon® Tip Catheter
By physicians and qualified health care professionals in angiographic procedures
FluoroSet Radiographic Tubal Assessment Set
Instillation of contrast dye into the uterine cavity for radiographic evaluation; injection of appropriate contrast dye into the fallopian tubes for evaluation of tubal patency
Haskal Transjugular Intrahepatic Portal Access Set
Transjugular liver access in diagnostic and interventional procedures
Kumpe Access Catheter
Used in combination with a HiWire, Bentson or other flexible-tipped wire guide to gain difficult ureteral access
Liver Access and Biopsy Needle Set
Obtaining liver histology samples via a jugular vein approach
Neff D’Agostino Percutaneous Access Set
Single-puncture percutaneous access to facilitate placement of a .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Aprima Access Nonvascular Introducer Set
Single-puncture percutaneous access to facilitate placement of a .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Selective Salpingography Catheter with Beacon Tip
Injection of contrast medium into the fallopian tube(s) for selective salpingography
Transluminal Biliary Biopsy Forceps Set
Access to and biopsy of tissue within the biliary ductal system
White Lumax Guiding Coaxial Catheter
Delivery of angioplasty balloons and other types of interventional devices

Side Effects and Complications

Cook Medical received frequent reports of a problem called “polymer degradation.” That caused catheter tips to break. The catheters underwent a preliminary investigation that identified environmental conditions, such as storage temperature, humidity and the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within health care facilities, as possible contributing factors to the malfunction.

The following potential adverse effects occurred or may have occurred as a result of the polymer degradation of the catheters:
  • Loss of device function
  • Separation of a device segment leading to medical intervention
  • Complications resulting from a separated segment, such as device fragments lodging in the vascular system
Fragments within the vascular system could result in the following:
  • Heart embolism (blockage of blood vessel in the heart)
  • Lung embolism (blockage of blood vessel in the lung)
  • Occluding (restricting/blocking) blood flow to end organs

Polymer Degradation and Voluntary Recall Timeline

Cook Medical decided to voluntarily recall its product following what it described as “an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.”

Polymer degradation is the breakdown of material from heat, oxygen and mechanical stress. Other environmental causes can cause the failure.

The company initially received 26 reports of the device malfunctioning, with 14 of those reports resulting in adverse events. That prompted a lot-specific recall on July 2, 2015. The recall was expanded in October 2015 for all lots of select sizes of catheters. It was expanded again in April 2016 to include all lots of catheters with Beacon Tip technology.

The voluntary global recall ultimately included a total of 4,146,309 catheters.

Recall Timeline
  • July 2015
    Cook Medical initiated a lot-specific voluntary recall of 2,239 lots of Beacon Tip Angiographic Catheters, including specific versions and lot numbers of the Torcon NB Advantage Beacon Tip Catheters (Catalog Prefix HNBR5.0), Royal Flush Plus Beacon Tip High-Flow Catheters (Catalog Prefix HNR4.0) and Slip-Cath Beacon Tip Catheters (Catalog Prefix SCBR5.0). A total of 95,167 devices globally were also subject to this recall.
  • October 2015
    Cook Medical expanded the voluntary recall to include additional product lots of its following catheters: Torcon NB Advantage Beacon Tip Catheters, Royal Flush Plus Beacon Tip High-Flow Catheters, Slip-Cath Beacon Tip Hydrophilic Catheters and Shuttle Select Slip-Cath Catheters. Numbers of devices affected increased to 408,011 distributed throughout the U.S.
  • February 2016
    The FDA identified the voluntary recall as a Class I recall, the most serious type of recall.
  • April 2016
    Cook Medical expanded its voluntary recall to include all catheters with Beacon Tip technology. This recall included 4,146,309 catheters from all over the world.

Cook Medical’s Litigation History

Cook Medical is presently in the midst of litigation for two of its other malfunctioning devices: its pelvic repair system products and IVC filters. The manufacturer’s pelvic repair system, which is implanted in women suffering from stress urinary incontinence or pelvic organ prolapse, contributed to Cook Medical being named as one of five vaginal device manufacturers facing personal injury claims said to have occurred as a result of the defective product. The consolidated case is currently pending in the Southern District of West Virginia, MDL No. 2440.

Did You Know?
Cook Medical is currently involved in litigation for two of its other product lines – pelvic repair products and IVC filters.

Additionally, Cook’s IVC filters were found in a study to have high rates of perforation, piercing the wall of the vein in which they were implanted. They were also found to frequently move from their original positions. Over 100 resulting lawsuits were consolidated into a multidistrict litigation (MDL) court in 2014 where the case is now pending in the Southern District of Indiana, MDL No. 2570.

Potential Angiographic Catheter Lawsuits

Currently, Cook Medical is not facing any lawsuits regarding the malfunction of its Beacon Tip Angiographic Catheters. However, several law firms are presently seeking out consumers who may have a case against the company for harm caused by its defective catheters. Many law firms are still collecting client information and many consumers may still be presenting themselves as potential candidates with possible claims for damages as victims of serious injury or death resulting from the use of one of the affected catheters utilizing the Beacon Tip technology.

Please seek the advice of a medical professional before making health care decisions.

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14 Cited Research Articles

  1. Cook Medical. (2015). 510(k) Summary. Retrieved from: https://www.accessdata.fda.gov/cdrh_docs/pdf13/k133130.pdf
  2. Cook Medical. (2016). Urgent: Medical Device Recall. Retrieved from: http://www.hsa.gov.sg/content/dam/HSA/HPRG/Medical_Devices/Updates_and_Safety_reporting/Field_Safety_Corrective_Action/FSN/2016/May/HSA%206004101-013-16-03_25%20FSN.pdf
  3. FDA. (2015). Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall – Catheter Tip May Slip or Separate. Retrieved from https://wayback.archive-it.org/7993/20170404200800/https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457663.htm
  4. FDA. (2015). Cook Medical Issues Global Recall of Beacon Tip Angiographic Catheter Products. Retrieved from: https://wayback.archive-it.org/7993/20170406094639/https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2015/ucm457068.htm
  5. FDA. (2015, oCTOBER 9). Cook Medical Expands Global Recall of Select Sizes of Beacon Tip Angiographic Catheters. Retrieved from: https://wayback.archive-it.org/7993/20170406093923/https://www.fda.gov/Safety/Recalls/ArchiveRecalls/2015/ucm466545.htm
  6. FDA. (2016). Cook Medical Expands Recall for Beacon Tip Angiographic Catheters to Include Additional Product Lots. Retrieved from: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm487797.htm
  7. FDA. (2016). Cook Medical Issues Global, Voluntary Recall of Catheters with Beacon Tip Technology. Retrieved from: https://www.fda.gov/Safety/Recalls/ucm499055.htm
  8. Gardette, J.-L. (n.d.). Polymer Degradation and Stability. Retrieved from: https://www.journals.elsevier.com/polymer-degradation-and-stability
  9. Johns Hopkins Medicine. (n.d.). Overview of the Vascular System. Retrieved from: http://www.hopkinsmedicine.org/healthlibrary/conditions/cardiovascular_diseases/overview_of_the_vascular_system_85,P08254/
  10. Merriam-Webster. (n.d.). Polymer. Retrieved from: https://www.merriam-webster.com/dictionary/polymer?utm_campaign=sd&utm_medium=serp&utm_source=jsonld
  11. Radiological Society of North America, Inc. (RSNA). (2016). Catheter Angiography. Retrieved from: https://www.radiologyinfo.org/en/info.cfm?pg=angiocath
  12. United States District Court Southern District of Indiana. (n.d.). MDL Case Information. Retrieved from: http://www.insd.uscourts.gov/mdl-case-information
  13. United States District Court Southern District of West Virginia. (2017). MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation. Retrieved from: https://www.wvsd.uscourts.gov/MDL/2440/index.html
  14. University of Washington. (n.d.). Polymers. Retrieved from: http://depts.washington.edu/matseed/mse_resources/Webpage/Polymer/polymers.htm
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