Flexor Check-Flo Introducer and Flexor Tuohy-Borst Side-Arm Introducers

Flexor Check-Flo Introducer and Flexor Tuohy-Borst Side-Arm Introducers

Have you been injured by a defective Flexor Introducer catheter manufactured by Cook Medical?

Tens of thousands of these catheters were recalled due to a dangerous defect that can cause life-threatening complications during a surgical procedure.

At Rosenbaum & Rosenbaum, P.C., we will help you hold the manufacturer accountable for their negligence.

As a victim harmed by a defective medical device, you may be entitled to compensation from the manufacturer. A New York defective medical device lawyer at our law office is here for you. Contact our law firm today to request a free consultation to learn more.

How Rosenbaum & Rosenbaum, P.C. Can Help With Your Cook Flexor Check-Flo Catheter Lawsuit

How Rosenbaum & Rosenbaum, P.C. Can Help With Your Cook Flexor Check-Flo Catheter Lawsuit

Medical devices should improve your health and quality of life, not harm you.

Yet, medical devices have caused over 80,000 deaths between 2008 and 2018 alone in addition to hundreds of thousands of injuries. 

When you are injured by a bad medical device, you deserve a New York personal injury lawyer who will fight for you and the full compensation you deserve.

Cases involving product liability are notoriously complex and not all personal injury lawyers handle these claims. Rosenbaum & Rosenbaum, P.C. has been representing clients for over 40 years against manufacturers and major insurance companies. Our firm has been recognized as one of America’s Top 100 Attorneys with a 10.0 Superb AVVO rating.

When you choose Rosenbaum & Rosenbaum, P.C. to represent you, you can count on our NYC defective product injury lawyers to:

  • Offer sound legal advice and guidance
  • Investigate how many other people suffered similar injuries
  • Analyze the specific product involved in your injury
  • Gather proof that the defective catheter was responsible for your injuries
  • Evaluate the full extent of your injuries and damages with medical and financial experts
  • Negotiate a fair settlement offer with the insurance company
  • Take your case to court if a settlement can’t be reached that fully compensates you 

Being injured by a medical device while seeking necessary treatment can be traumatic and frightening. Cook Medical must be held accountable for the suffering you’ve endured. Rosenbaum & Rosenbaum, P.C. is here to help you hold them accountable and recover compensation to move on with your life. Schedule a free consultation today with our Cook Medical Flexor Introducers injury lawyers to find out how we can help.

Global Recall of Two Cook Medical Catheter Introducers

Cook Medical announced a voluntary recall of two catheter products on November 24, 2020, over reports of injury and the potential for serious harm.

The recall affects two products:

  • Flexor Check-Flo Introducer
  • Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) 
Global Recall of Two Cook Medical Catheter Introducers

The products were manufactured between February 17, 2020 and September 29, 2020. The recalled devices were distributed between May 23, 2020 and November 17, 2020.

The list of affected catalog and lot numbers is available here.

Affected health care customers have been advised to return the recalled devices to Cook Medical and report any adverse events.

The FDA has classified this recall as a Class I recall, the most serious type. In a Class 1 recall, there is a reasonable probability that use of the device will cause serious adverse health risks or death.

What Are Flexor Catheters?

The Flexor catheter devices are single-use flexible tubes used to introduce therapeutic or diagnostic devices into blood vessels. The Introducers line of catheters have a coated shaft, dilator, valve, and distal radiopaque markers that allow them to show up on x-rays. They may be used to insert medical devices into blood vessels during surgery and procedures but were not used to access blood vessels of the brain or heart.

Why Were the Flexor Catheter Introducers Recalled?

The Cook Medical catheters have been recalled due to an abnormally high failure rate at a specific bond site approximately 8-11cm from the distal end of the sheath.

There is a high potential for the device to come apart during use. This may lead to life-threatening events.

When a device fails, adverse events may include:

  • Longer surgery time
  • Need for an additional procedure to remove separated catheter pieces
  • Blocked blood flow to organs
  • Bleeding
  • Blood vessel injury 

While no deaths have yet been reported, the catheters have already been linked to more than one dozen serious injuries.

Who Is Affected by the Flexor Check-Flo Introducer Recall?

The FDA recall came after 57 complaints about issues with the catheters and 14 serious injuries. No deaths have yet been reported, but the recall does state that using the devices could result in death. The recall so far involves almost 59,000 devices.

Health care providers using the affected catheters as well as patients who have had or will have procedures with the devices are affected. The Flexor devices were used mostly by Interventional Radiologists in imaging procedures.

Cook Medical Can Be Liable For Your Flexor Catheter Injuries in New York – Here’s Why

We count on medical advances, medication, and devices to improve our lives and our health. Unfortunately, thousands of people every year are instead injured by medical devices that are defective or dangerous. A defective medical device can instead harm your quality of life, necessitate further medical treatment, or even result in wrongful death.

So, if you’ve been injured by a dangerous or defective medical product like Cook’s Flexor catheter, you may have an injury claim under New York product liability law. Manufacturers have a duty to ensure their products are safe. 

Flexor Introducer lawsuits could potentially seek damages based on the fact that the device is dangerous due to defects in:

  • Design,
  • Manufacturing, or
  • Warning 

Rosenbaum & Rosenbaum, P.C., has 40+ years of experience representing clients in mass tort litigation and cases involving defective medical devices. We’ve gone up against some of the most powerful pharmaceutical companies, medical device manufacturers, and insurance companies in the nation – and emerged victoriously for our clients. When you enlist our help, we’ll dig deep, determine why your Cook Flexor Introducer was defective, and work tirelessly to prove it in a court of law. When we do, we can help you get the money you deserve.

How Was Cook Able to Get FDA Approval For a Dangerous Product? 

Before a medical device is released on the market, it generally goes through an in-depth testing process to ensure it is generally safe. Despite this, manufacturers sometimes cut corners. If a similar product is on the market, the manufacturer must simply show their new product is at least as safe as the existing product. 

This is a loophole called 510(k) clearance.

The purpose of this loophole is to allow medical devices to quickly enter the market without a long approval process if similar products already exist. When it works well, it allows new products with better safety to replace older products. 

However, many medical devices have been on the market for decades before the FDA tightened safety rules and testing. A company may simply need to show their new product is at least as safe as a fairly untested older device.

What Damages Are Available If I’ve Been Injured By a Cook Medical Flexor Introducer Device?

Any type of defective product can cause life-changing injuries, but medical devices pose a unique risk. Devices like the Cook Medical Flexor catheters are used during delicate surgical procedures on patients who may have health conditions that put them at higher risk of complications. 

When a device fails, patients may be forced to undergo additional risky procedures or face serious complications like excessive bleeding and blocked blood flow to organs.

When you are injured by a defective medical product, you have the right to compensation for the damages you sustained. 

The defective medical device lawyers at Rosenbaum & Rosenbaum, P.C. will seek maximum compensation for your:

  • Medical bills, including future anticipated medical expenses related to your injury. This can include surgery, hospitalization, medication, doctor visits, medical devices, physical therapy, and home care.
  • Lost wages for time you needed to take off work related to your injury
  • Lost earning potential if your injury leaves you disabled and unable to return to work
  • Pain and suffering
  • Emotional distress
  • Mental anguish
  • Loss of enjoyment of life 

If your loved one is killed due to a defective device, you may be entitled to damages through a wrongful death claim.

To determine the value of your case, our lawyers will use years of experience and the resources available to us. We will work with relevant specialists and experts in various fields like finance and medicine to determine the severity of your injuries and how they will impact your future.

How Long Do I Have to File a Cook Flexor Cathter Lawsuit in New York?

It’s important to note that time is limited to file an injury claim. If you are injured by a defective Flexor catheter, you have three years from the date of the injury under the New York statute of limitations. Do not delay in contacting a personal injury attorney about a claim regarding a Cook Medical catheter, however. Product liability cases are complicated and may require lengthy investigation.

Depending on the extent of injuries and the number of people ultimately affected by the Cook Medical Flexor recall, a class action may be justified. However, this will only be apparent after an investigation.

Contact Our New York Product Liability Lawyers for a Free Consultation

Have you suffered an injury due to a defective Cook Medical Flexor catheter? You may be entitled to damages for the injuries you have suffered. Rosenbaum & Rosenbaum, P.C. is here to fight for your rights and help you pursue your claim. Contact our law office to schedule a free consultation with a compassionate New York defective medical device lawyer to begin exploring your legal options.