Penumbra’s JET 7 Xtra Flex Catheter may cause unexpected death or serious injury. If you or a family member have been injured by the Penumbra device, you may have the right to take legal action and secure a financial award.
The experienced NYC personal injury attorneys at Rosenbaum & Rosenbaum, P.C., can help you file a Penumbra catheter lawsuit and fight for maximum compensation.
Contact our New York City law offices to arrange a free consultation to discuss your legal rights and options today. We’re here to answer whenever you call – 24/7/365.
Why You Need Rosenbaum & Rosenbaum, P.C., In Your Corner If You’ve Been Injured By a Penumbra Catheter
Catheters and other medical devices shouldn’t fail. They should be thoroughly tested before they’re ever permitted to be used on patients. Unfortunately, that’s not always the case.
Case in point: the JET 7 Xtra Flex Catheter – manufactured and sold by Penumbra, Inc.
Penumbra had a responsibility to ensure that the product sold to assist in your medical treatment was safe. Penumbra failed. And now, thousands of stroke patients around the nation have either been injured, died, or are in very present danger. The medical device manufacturer must be held to account.
Going up against a huge corporation like Penumbra, Inc. isn’t an easy task. That’s why you need an experienced NYC personal injury attorney from Rosenbaum & Rosenbaum, P.C., standing beside you.
At Rosenbaum & Rosenbaum, P.C., we’ve been fighting for injury victims in New York City for more than 40 years. Collectively, our attorneys have more than a century of experience handling the most complex injury disputes imaginable. If you’ve been injured because of a defective Penumbra catheter, you can count on us to help you fight for the money you deserve.
- We’ll conduct a thorough investigation into the circumstances that led to your injury and search for evidence to connect your injury to the defective catheter.
- We’ll enlist the aid of respected experts in NYC – including medical professionals who can help us build a strong case against Penumbra on your behalf.
- We’ll determine if your health care provider knew or should have known about the potential risks associated with the Penumbra catheter.
- We’ll handle negotiations with the insurance company, corporation, and other defendants on your behalf.
- We’ll have our accomplished trial attorneys argue your case before a jury if you aren’t extended a fair settlement offer.
We know this is a difficult time for you. Our personal injury attorneys in NYC are here to help make things easier. Give our law firm a call to arrange a time to discuss the details of your case. As always, your initial evaluation is free.
Penumbra Device Dubbed “Killer Catheter”
In November 2020, a bombshell report issued by Quintessential Capital Management (QCM) concluded that Penumbra’s JET 7 Xtra Flex device suffers from a “structural design flaw that makes it prone to critical malfunctioning.” In just 14 months on the market, Penumbra catheters have been responsible for causing at least:
- 17 deaths, and
- 35 brain injuries.
Food and Drug Administration (FDA) records indicate that the agency received more than 200 reports of adverse events during that period of time.
What’s more, QCM believes that Penumbra knew that its catheter was defective and posed a serious risk to patients, but decided to keep it on the market, anyway.
If Penumbra knew or should have known that its JET 7 Xtra Flex devices were defective or unreasonably dangerous, the company can be held legally and financially accountable for resulting harm.
In New York, product manufacturers – not excluding medical device companies – can be held strictly liable for product defects.
How Is the Penumbra Xtra Flex Catheter Defective?
Before we dive into the alleged defects, it’s important to consider how the device should work. The Penumbra JET 7 Xtra Flex is a reperfusion catheter. A reperfusion catheter is a small tube that’s inserted into the brain and used to extract thrombus – or blood clots – from stroke patients.
The Penumbra JET 7 Xtra Flex catheters are marketed as being more flexible than other reperfusion catheters. However, this flexibility appears to have affected the structural integrity of the device. Doctors, surgeons, and catheter recipients have indicated that the distal tip of the catheter has broken off while the device is used.
When the distal dip breaks or malfunctions, it can begin to float around in the blood vessel, uncontrolled. Alternatively, the device can begin to “leak.”
Potential consequences and adverse effects of this include:
- Hemorrhaging in the brain
- Blockage of blood flow
- Cerebral infarction
- Vessel damage, and
In addition to posing a serious and imminent risk to the patient, device malfunction also causes the procedure to take longer than it normally should. The longer a procedure takes to complete, the higher the risk of complication and the need for additional surgeries.
Penumbra’s JET 7 reperfusion catheter with Xtra Flex technology is defective because the device is prone to malfunction and breakage during use. It is not reasonably safe. And there’s evidence to suggest that Penumbra knew its device was not structurally sound. Rather than take it off the market, Penumbra hid this information and, to make matters worse, tried to blame surgeons and doctors for resulting injuries and deaths, instead.
Has the Penumbra JET 7 Xtra Flex Catheter Been Recalled?
Yes. Penumbra issued an urgent and voluntary recall for its defective Xtra Flex catheters on December 15, 2020, citing a “ risk of unexpected death or serious injury while used for removing clots in stroke patients.”
According to the FDA, the following devices are included in the recall:
- The JET 7 Xtra Flex catheter, and
- The JET 7MAX configuration (which includes the JET 7 Xtra Flex catheter and MAX Delivery Device).
However, it should be noted that the company’s recall comes months after issues were first identified by the FDA.
On July 27, 2020, the FDA prompted Penumbra to issue a “Notification to Healthcare Providers” with information about additional warnings and precautions when using the device.
And, on August 31, 2020, the FDA supplemented the notice to include a warning against using contrast injection through the device.
Only after the FDA formally asked the manufacturer to remove the device from the market was the voluntary recall issued.
Do I Have a Penumbra Xtra Flex Catheter Injury Lawsuit?
Just because Penumbra recalled its catheter doesn’t mean that the company is immune from litigation.
You may have the right to file a lawsuit against Penumbra, Inc. if:
- Your doctor or surgeon used a JET 7 Xtra Flex catheter to remove blood clots
- The catheter broke or malfunctioned while in use, and
- You suffered injuries or complications, or were required to undergo additional surgical procedures, as a result.
You may also have the right to file a wrongful death lawsuit if someone you love has died because of a defective JET 7 Xtra Flex catheter device.
The only way to know if you have the right to file a lawsuit – and if you have a strong case – is by getting in touch with an experienced personal injury lawyer.
Don’t hesitate to call Rosenbaum & Rosenbaum, P.C., for immediate legal assistance. Our team would be happy to assist you and help you identify the legal options that might be available to you at this time.
Damages Available to Individuals Harmed by the Penumbra Catheter
Under New York state product liability law, companies like Penumbra can be held strictly liable if a product it designed, manufactured, and/or marketed is defective. If you or a loved one has been injured, Rosenbaum & Rosenbaum, P.C., can help file a product liability lawsuit on your behalf and seek maximum compensation.
Victims of defective Penumbra catheters might be entitled to monetary damages for:
- Medical bills, including expenses related to additional procedures necessitated by the malfunctioning device
- Lost wages and income
- Disability and reduced earning capacity
- Mental anguish
- Pain and suffering
- Loss of quality of life
- Wrongful death
Personal injury claims involving defective medical devices tend to be complicated. You need to make sure that you work with a law firm that has experience navigating these complexities and the resources needed to prevail.
At Rosenbaum & Rosenbaum, P.C., we’ve been representing clients in actions involving dangerous drugs and defective medical devices for decades. Our attorneys have an incredibly in-depth understanding of the laws, rules, and procedures that will be applicable to your case. We’ve gone toe-to-toe with some of the biggest names in medical devices and the medical industrial complex – and won.
We appreciate just how devastating the fallout from a defective catheter can be, and we’re here to help you fight for what you deserve.
Are Penumbra Catheter Lawsuits a Class Action?
No. However, as the number of acute ischemic stroke patients affected by the defective Penumbra catheter becomes more clear, and as the number of lawsuits rises, there’s a chance that the litigation will be consolidated into an MDL.
An MDL – or multidistrict litigation – is similar to, but distinct from, a class action. In an MDL, cases are merged to be tried in one federal court, rather than spread out in state courts across the country. With one judge presiding, there’s a better chance of uniform results. At the end of the day, every plaintiff in a Penumbra catheter lawsuit is entitled to his or her own day in court and his or her own individual case result.
Rosenbaum & Rosenbaum, P.C., has decades of experience representing clients in mass tort litigation. Our attorneys are uniquely qualified to help you navigate the challenges that might lie ahead. Give us a call to learn more about how we can help you today.
Schedule a Free Consultation to Discuss Your Penumbra Catheter Lawsuit
Our New York City personal injury lawyers are available to discuss your legal rights and options. If you’ve been injured because of a defective Penumbra catheter or have suffered the devastating loss of a family member, please don’t hesitate to give us a call. We can explain your options and help you move forward with a Penumbra catheter lawsuit in pursuit of the compensation you deserve.