A global Cook Medical catheter recall has been issued involving Beacon Tip angiographic catheters that have been found to exhibit tip slitting or separation, which can result in serious injury to the patient. The catheters were distributed globally between September 2012 and September 2015, defective medical device attorneys note. It is anticipated that Cook Medical Catheter lawsuits will be filed as a result of the recall.
If you or a loved one suffered an injury as a result of a defective medical device, including the recalled Beacon Tip catheters, contact Attorney Group for more information about your options. We can answer your questions in a free, confidential, no-obligation consultation, and if you wish to pursue a claim, we can connect you with an affiliated medical device recall lawyer who can assist you through the legal process.
What are Beacon Tip Angiographic Catheters?
Beacon tip angiographic catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a cardiac angiogram used to diagnose heart conditions. The manufacturer, Cook Medical, received complaints that the catheter tip may split or separate from the catheter. If this should occur, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and would require additional medical intervention to retrieve the tip, or may even cause death.
The catheter recall includes:
- Torcon NB Advantage beacon tip catheters
- Royal Flush Plus beacon tip high-flow catheters
- Slip-Cath beacon tip catheters
- Shuttle Select Slip-Cath catheters
In February 2016, the Cook Medical Catheter Recall was expanded to include over 408,000 units in the U.S. alone. Following the expanded recall, Cook Medical initiated a voluntary recall of over 4 million catheters with Beacon Tip technology because the devices have been found to exhibit polymer degradation of the catheter tip, resulting in tip fracture and/or separation. As a result, 30 Medical Device Reports had been made as of the global recall date.
Cook Beacon Tip Adverse Events
The FDA website has over 150 adverse event reports involving Beacon Tip angiographic catheters. Some reports state that the device broke while in their patients’ bodies and that pieces of the device remain in their arteries. Other patients have undergone surgery to remove pieces that traveled to femoral arteries or other areas and are requiring additional cardiac care and monitoring.
According to the FDA’s recall information, potential adverse events that may occur as a result of catheter polymer degradation could include:
- Loss of device function
- Separation of a device segment leading to medical intervention
- Complications resulting from a separated segment
These complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
Other Cook Medical Litigation
Cook Medical is the world’s largest private medical device manufacturer and one of three divisions that form Cook Group Incorporated, a 42-company conglomerate. In addition to the Cook Medical catheter recall, the company has been involved in a number of defective medical device litigations related to its IVC filter, transvaginal mesh and similar products, according to ibj.com.
How a Cook Medical Catheter Recall Lawsuit Can Help
Device makers have a duty to design and produce safe products, and to warn of possible risks associated with their products. Failure to fulfill that duty can result in injuries to patients, and the device maker being held liable for those injuries.
Patients who are injured by defective medical devices may be entitled to compensation for damages resulting from injuries. Compensation can be based on factors including:
- Medical expenses
- Lost wages
- Ability to work
- Pain and suffering from an injury
If a loved one dies from complications with a defective medical device, his or her family members may be able to pursue claims for wrongful death damages, which include:
- Pain, suffering, and mental anguish resulting from the loss of a loved one
- Conscious pain and suffering of a loved one prior to death
- Loss of financial support
- Medical expenses attributable to the fatal injury
Affected patients should speak to a Cook Medical Catheter lawsuit attorney to learn more about the rights and remedies.
If you have been injured by a defective medical device, or have additional questions about the Cook Medical Catheter recall, contact Attorney Group for more information.
When you contact us, an attorney will follow up with you to speak with you about your case or answer questions that you might have. There is no cost or obligation to speak with us, and any information you provide will be kept confidential.
Please note that the law limits the time you have to pursue a claim for an injury. If you think you have a case, you should not delay taking action.