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No. Only the Cordis Supertorque MB Angiographic Catheter with Marker Bands is under recall due to the issues present with the marker bands. Other Cordis catheters are not recalled.

Angiographic catheters, like the Cordis Super Torque MB Angiographic Catheter with Marker Bands, are generally used on patients receiving a procedure called a coronary angiogram, which uses X-ray imaging to see your heart’s blood vessels. According to the Mayo Clinic, the test is generally done to see if there’s a restriction in blood flow going to the heart. Coronary angiograms are part of a general group of procedures known as cardiac catheterizations. Cardiac catheterization procedures can both diagnose and treat heart and blood vessel conditions, and a coronary angiogram, which can help diagnose heart conditions, is the most common type of cardiac catheterization procedure.

Out of 25,000 devices recalled, there have been 8 documented injuries and 167 complaints. No deaths have been reported as a result of using this device in medical procedures. 

 

Yes, in their 2020 Cardiovascular Catalog, there are a few warnings about use of the Angiographic Catheter with Marker Bands: 

  • Failure to observe these instructions may result in damage, breakage or separation of the catheter or the markerbands, which may necessitate additional intervention. 
  • Manipulation of the catheter under excessive friction due to interaction with other devices or while trapped in the vasculature, can lead to stretching or elongation of the catheter. 
  • Stretching or elongation of the catheter during endovascular procedures could result in the marker bands moving along the catheter. In extreme cases, marker bands may come off the catheter and dislodge into the vascular system.

What are Cordis Angiographic Catheters?

The Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands is a catheter used to visualize and measure parts of the vascular system in order to diagnose disease and pinpoint or understand the extent of vascular issues. The Radiopaque Marker Bands used with the device are detectable by X-Ray, allowing physicians to accurately insert the device and monitor its placement. 

Cordis Corporation, once owned by Johnson & Johnson and later Cardinal Health, is now owned by private equity firm Hellman and Friedman.

 

When are Angiographic Catheters Used?

Angiographic catheters, like the Cordis Super Torque MB Angiographic Catheter, are generally used on patients receiving a procedure called a coronary angiogram, which uses X-ray imaging to see your heart’s blood vessels. According to the Mayo Clinic, the test is generally done to see if there’s a restriction in blood flow going to the heart. Coronary angiograms are part of a general group of procedures known as heart (cardiac) catheterizations. Cardiac catheterization procedures can both diagnose and treat heart and blood vessel conditions, and a coronary angiogram, which can help diagnose heart conditions, is the most common type of cardiac catheterization procedure.

 

Product Defects

The gold-alloy marker bands used in the device have been seen to move, lose their position, come loose from the catheter, or cause delays in angiographic procedures. These defects can cause major, adverse health effects like heart attack and stroke and could lead to the requirement of further procedures.

The company has stated that manufacturing is not at fault for these problems, but misuse by those inserting the device are to blame.  

 

Is the Cordis Super Torque MB Angiographic Catheter recalled?

The device is under a Class I recall, the most serious recall the FDA can issue. Around 25,000 of these devices produced and distributed between January 2019 and July 2021 are affected by the recall. 

Specific models under recall include the Super Torque MB 5F Pig, the 5F Super Torque Pig Pigtail Special, and ​​the 5F Universal Flush F4 Super Torque MB Special. The recall does not involve devices that do not come with marker bands. 

 

Dislodging Marker Bands Defect

Similar to a case from a decade ago where a marker band dislodged from a Cordis catheter, was trapped in a patient’s vascular system and required a stent and procedure to fix the problem, the recent recall is also related to marker bands losing their position. As a trapped catheter is removed by a surgeon, the device can become stretched and lead to marker bands changing position and becoming dislodged

 

What are marker bands?

Marker bands are used to identify the location of the catheter tip. Marker bands are typically installed on catheters in a process called swaging, This method of adhesion is performed using a swaging machine, essentially hammering the marker band onto the extruding catheter tip. The marker band is mechanically bonded onto the tip but is still exposed on the outer diameter, which can lead to possible movement of the marker band(s) during procedures as the catheter is moved through the body. 

 

Cordis Angiographic Catheter Injuries

Injuries involving the Cordis Angiographic Catheter typically happen in the circumstance that a catheter is trapped between another device and the vessel wall. Eight patient injuries have been reported along with 167 complaints. No deaths have been reported. 

Though the FDA did not disclose what exactly could cause heart attacks with the Cordis device, heart attacks during cardiac catheterization have been triggered by blood clots forming during the procedure.

As with risk of heart attack, the FDA did not disclose what exactly could trigger stroke when administered a Cordis device. Strokes have been linked to/triggered by blood clots forming during cardiac catheterizations. 

With the danger of misplacement and dislodging of the marker bands used with the Cordis device, damage to the vascular system is possible. 

Cordis device malfunction may lead to the requirement of further medical procedures to reverse issues caused and ensure patient safety. This can be costly to a patient, both in terms of medical and financial burden. 

What to Do if Injured

If you are suffering from an injury related to a Cordis Angiographic Catheter malfunction, there are steps you can take to minimize the damages caused by your injury and gain compensation for those injuries. 

 

Report Your Injuries

Reporting your injuries to the FDA is an important step in ensuring justice is achieved. Voluntary reports can be submitted through MedWatch. Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.

 

Do I Qualify for a Cordis Angiographic Catheter Lawsuit?

If you or a loved one underwent a procedure where a Cordis Angiographic Catheter with Marker Bands was used and subsequently suffered injuries or complications including: 

  • Heart attack
  • Stroke
  • Damage to the vascular system
  • Requirement of further medical procedures due to device malfunction

 

you may qualify for a Cordis Angiographic Catheter injury lawsuit. Contact TorHoerman Law today or use our chatbot below to get a free, instant online case evaluation right now.

 

What to do if you qualify

If you do qualify for legal action, there are a few steps you should take to prepare for your lawsuit: 

  • Mitigation
  • Consultation

 

Mitigation

To mitigate damages is the process in which the injured party minimizes that costs & losses incurred as a result of an accident.

Some important step to mitigation include:

  • Get a diagnosis of your injuries from a medical professional as soon as possible
  • Seek medical treatment for all diagnosed injuries
  • Follow your doctor’s orders
  • Do everything in your power to limit the physical and financial impacts of your injuries

Mitigation is an important step in building a strong & honest case in your favor.

 

Consultation

You should consult with an injury attorney to discuss your legal options. After consulting with at least one attorney, consider the benefits of hiring an injury lawyer to represent you in your Cordis Angiographic Catheter injury lawsuit.

You can get a free, no-obligation consultation from a THL attorney today.

Remember, the statute of limitations limits the amount of time you have to take legal action after an incident or injury, so do not hesitate to initiate the process and talk to a lawyer as soon as possible.

 

Filing a Cordis Super Torque MB Angiographic Catheter Lawsuit

The civil litigation process requires extreme attention to detail and can be overwhelming for someone who does not possess extensive legal knowledge. Hiring an experienced personal injury attorney can help you in the process of building a strong case and then use his or her knowledge of the court system to litigate on your behalf. 

 

What will my attorney do?

An experienced Cordis Angiographic Catheter Injury Lawyer can help you to:

  • Determine liability
  • Gather evidence
  • Assess damages
  • Build a strong case
  • Navigate the litigation process
  • Get you compensated for your injuries

 

Speak or chat with a professional at TorHoerman Law today for a free, no-obligation legal consultation  to see if you qualify for a Cordis Angiographic Catheter injury lawsuit. 

 

How much does a Cordis Angiographic Catheter lawyer cost?

At TorHoerman Law, our attorneys operate on a contingency fee basis, meaning that we do not charge legal fees to our clients until after they have been awarded compensation for their Cordis Angiographic Catheter injuries. 

 

TorHoerman Law, Cordis Angiographic Catheter Injury Lawyers

At TorHoerman Law, we have won more than $4 billion in verdicts and negotiated settlements for our clients. Our attorneys have more than a century of combined experience litigating medical device cases. Our results and expertise speak for themselves.

If you or a loved one have suffered an injury due to this defective product, contact a Cordis Angiographic Catheter lawyer at TorHoerman Law today to discuss your legal options or use our chatbot below to get a free instant online case evaluation right now!

 

 

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